This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children (NCT00978068), a randomized phase 3 study. The primary outcome is Incidence-density of Malaria Defined as the Number of Incident Episodes of Malaria Per Time at Risk..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00978068 |
| Phase | Phase 3 |
| Condition | Malaria, HIV Infections |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 176 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of California, San Francisco |
| Results posted | Yes |
2. Clinical Question
Population
The trial enrolled HIV-infected children in Uganda, where malaria transmission is a concern. The registry describes children receiving insecticide-treated bed nets and TS, but does not explain the abbreviation TS. It reports an enrollment of 176 and gives the number in each treatment arm with the outcome results. Further eligibility details and the characteristics of the enrolled children are not reported in the registry record.
Intervention
The intervention was an antiretroviral therapy regimen containing lopinavir/ritonavir (LPV/r) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs). The registry describes this as a regimen children could start or continue, and the follow-up period was intended to extend for at least 24 months or until the end of the study. The record does not report additional details about treatment changes or adherence.
Comparator
The comparison group received the standard Ugandan first-line regimen described in the registry: nevirapine (NVP) or efavirenz (EFV) plus 2 NRTIs. Treatment assignment was randomized, and the trial was open label, meaning the registry reports no masking. The record does not describe whether outcome assessors were masked.
Primary question
The primary question was whether the malaria incidence-density differed between the LPV/r-based regimen and the NVP- or EFV-based regimen. Incidence-density is the number of incident malaria episodes relative to time at risk, rather than simply the proportion of children who ever had malaria. The posted comparison is an incidence rate ratio from negative binomial regression. The registry does not report whether the analysis included covariate adjustment or how recurrent episodes were handled beyond the stated method.
3. Trial Design
This was a randomized, open-label, parallel-group Phase 3 trial sponsored by the University of California, San Francisco. The registry lists an enrollment of 176 and identifies malaria and HIV infections as the conditions studied. The trial began in 2009-09, had a primary completion date of 2013-01, and is recorded as completed. These registry entries describe the trial’s administrative design and status; they do not by themselves establish how closely each participant followed the intended treatment or follow-up schedule.
Participants were assigned to one of two antiretroviral therapy strategies. One arm received lopinavir/ritonavir plus 2 NRTIs; the other received nevirapine or efavirenz plus 2 NRTIs. The arm results list 84.0 participants for the LPV/r group and 86.0 for the NVP- or EFV-based group. Since masking is listed as none, participants and trial personnel were not masked according to the registry record. Whether outcome assessors or analysts were masked is not reported in the registry record.
The primary outcome was malaria incidence-density, expressed as episodes per person-year at risk. Its timeframe is described as time from randomization to at least 24 months of follow-up or until the end of the study. This endpoint allows the analysis to relate the count of episodes to time at risk, which can be useful when participants contribute different amounts of observation time or can experience repeated episodes. The record does not give further details about censoring, loss to follow-up, or the definition of the time-at-risk interval.
Five secondary outcomes are posted, covering adverse events following antimalarial therapy, complicated malaria, first malaria episodes, recurrent parasitemia, and recurrent malaria. The registry record does not report the trial’s sample-size justification, a prespecified statistical analysis plan, or interim analyses.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: A total of 404 children were screened for eligibility; 228 were found not to be eligible. The main reasons for ineligibility were: 136 Were not eligible for ART 34 Were on ART with detectable viral load 32 Were HIV- 8 Had not received ART but had prior exposure to nevirapine
Overall Study
| Stage | LPV/r + 2 NRTIs | NVP or EFV + 2 NRTIs |
|---|---|---|
| STARTED | 87 | 89 |
| Initiated Study Drugs | 84 | 86 |
| COMPLETED | 83 | 80 |
| NOT COMPLETED | 4 | 9 |
Reasons for not completing this period:
| Reason | LPV/r + 2 NRTIs | NVP or EFV + 2 NRTIs |
|---|---|---|
| Were Awaiting Initiation of ART | 2 | 2 |
| Death | 1 | 2 |
| Lost to Follow-up | 1 | 2 |
| Physician Decision | 0 | 1 |
| Unable to Comply with Study | 0 | 2 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | LPV/r + 2 NRTIs | NVP or EFV + 2 NRTIs | Total |
|---|---|---|---|---|
| Participants analysed | 84 | 86 | 170 | |
| Age, Continuous | years | 2.9 (0.7 to 6.0) | 3.1 (0.5 to 5.9) | 3.1 (0.5 to 6.0) |
| Sex: Female, Male: Female | Participants | 41 | 41 | 82 |
| Sex: Female, Male: Male | Participants | 43 | 45 | 88 |
| Previous ART to Enrollment: No Previous ART | participants | 57 | 58 | 115 |
| Previous ART to Enrollment: Previous ART | participants | 27 | 28 | 55 |
| WHO Clinical HIV stage: Stage I (Asymptomatic) | participants | 60 | 66 | 126 |
| WHO Clinical HIV stage: Stage II (mod. unexplained weight loss) | participants | 16 | 15 | 31 |
| WHO Clinical HIV stage: Stage III (unexplained severe weight loss) | participants | 2 | 1 | 3 |
| WHO Clinical HIV stage: Stage IV (HIV wasting syndrome) | participants | 6 | 4 | 10 |
| CD4 Percentage: No Previous ART | % of white cells that are CD4 cells | 14 (2 to 44) | 16 (2 to 43) | 16 (2 to 44) |
| CD4 Percentage: Previous ART | % of white cells that are CD4 cells | 31 (8 to 51) | 30 (10 to 45) | 30 (8 to 51) |
| Viral Load: No Previous ART | log10copies/mL | 5.4 (0 to 6.4) | 5.5 (0 to 6.4) | 5.5 (0 to 6.4) |
| Viral Load: Previous ART | log10copies/mL | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
| Hemoglobin | g/dL | 10.4 (SD 1.3) | 10.6 (SD 1.5) | 10.5 (SD 1.4) |
| Result of Baseline Blood Smear for Asexual Parasites: Positive | participants | 10 | 11 | 21 |
| Result of Baseline Blood Smear for Asexual Parasites: Negative | participants | 74 | 75 | 149 |
6. Primary Endpoint
The registry lists the primary outcome as Incidence-density of Malaria Defined as the Number of Incident Episodes of Malaria Per Time at Risk., measured over Time from randomization to at least 24 months of follow up or until end of the study.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Episodes/ Person-Yr at Risk |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is incidence-density of malaria: the number of incident malaria episodes divided by the time participants were at risk. It is reported in episodes per person-year at risk. Unlike a measure that only records whether a participant experienced any malaria, this endpoint can reflect repeated episodes and the amount of observed time available for episodes to occur. It is therefore a way to compare the rate of events between groups when follow-up time may vary.
The registry states that follow-up ran from randomization to at least 24 months or until the end of the study. The endpoint’s interpretation depends on how episodes were identified and how person-time at risk was defined. Those operational details are not reported in the registry record. Nor does the record specify how time outside observation, treatment changes, or interruptions in follow-up were handled in the endpoint calculation.
The outcome is a count rate, not a direct measure of the probability that a child will experience malaria, the severity of each episode, or the effect on any individual child. Incidence-density can be clinically relevant when recurrent episodes matter, but it should be read alongside the outcome definition, follow-up information, and uncertainty in the group comparison. The registry’s inferential comparison uses a negative binomial regression estimate of the incidence rate ratio.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted arm-specific malaria incidence rates are 1.32 episodes per person-year at risk for the LPV/r plus 2 NRTIs group and 2.25 for the NVP- or EFV-based plus 2 NRTIs group. The registry reports an incidence rate ratio of 0.59 from negative binomial regression, with a 95% confidence interval from 0.36 to 0.97 and p = 0.04. The ratio compares the estimated event rate in the LPV/r group with that in the comparator group. A value below the ratio’s null value indicates a lower estimated rate in the LPV/r group, while the confidence interval expresses uncertainty about the size of that relative difference.
The reported interval ranges from 0.36 to 0.97. It is relatively broad, so the registry estimate does not identify a single precise rate ratio. Its upper end is close to the null value for a ratio, and the p-value is 0.04. These statistics describe the evidence under the stated model; they do not establish that the regimens differ for every participant or guarantee that the same estimate would be observed in another setting. The registry does not give an absolute between-group rate difference, and none should be inferred from the arm rates by calculating one.
The reported method is negative binomial regression, a model commonly used for event counts when the variation in counts can exceed what a simpler Poisson model allows. The registry does not report whether the model was adjusted for other variables, how it treated within-participant recurrence, or whether it incorporated any particular follow-up features. The posted ratio should therefore be interpreted as the registry’s reported model-based comparison, not as an independently verified causal estimate.
Randomization supports a comparative interpretation by assigning participants to treatment strategies, but the open-label design may affect care, reporting, or event ascertainment. The registry does not state whether malaria outcome assessment was masked, whether treatment adherence was measured, or how departures from assigned treatment were analyzed. These details matter when evaluating the possibility of bias.
The figures describe this trial’s enrolled population and follow-up period. They do not establish effects in children with different characteristics, in other settings, or under other care conditions. The result is specifically about the incidence-density endpoint and the two antiretroviral strategies compared. It is not a direct estimate of the risk of a first episode, complicated malaria, recurrent parasitemia, or adverse events; those are separate outcomes.
Confidence intervals and p-values address statistical uncertainty under an analysis model, not the clinical importance of an effect. The registry does not state a threshold for a clinically important difference. The data therefore support a reading of the reported rate comparison and its uncertainty, while leaving questions about clinical importance, generalizability, and analytic details unresolved.
9. Statistical Methods Explained
The primary result is a count-rate comparison. Each participant can contribute malaria episodes over time, so the outcome is not limited to one event per person. The registry expresses the group rates as episodes per person-year at risk and reports their comparison as an incidence rate ratio. The arm rates are 1.32 and 2.25 episodes per person-year at risk, and the model-based ratio is 0.59.
What does an incidence rate ratio express?
In general, a rate ratio compares the event rate in one group with the event rate in another. A ratio at the null value represents equal rates; a value below that point means the numerator group has a lower estimated rate, and a value above it means a higher estimated rate. Here, the reported ratio compares the LPV/r-based group with the NVP- or EFV-based group. It describes a relative rate, not a difference in the number of episodes or an individual participant’s probability of malaria.
Rate ratios can be useful when groups contribute different amounts of time at risk. The denominator represents time rather than simply the number of people enrolled. The registry reports the endpoint’s timeframe but does not provide the group-specific person-time totals or details of the time-at-risk calculation. The ratio should therefore be understood from the reported model estimate, without reconstructing it from the arm rates.
Why use negative binomial regression?
In general, count data often vary more than a simple count model expects. This is called over-dispersion. If a model assumes less variability than the data contain, uncertainty estimates can be too small. Negative binomial regression allows for extra variation in counts and is commonly used for recurrent event-rate comparisons when over-dispersion is a concern.
The registry names negative binomial regression as the method but does not report a dispersion estimate, model diagnostics, covariates, or other implementation details. It is not possible to determine from the record whether the model was adjusted, how repeated episodes within the same participant were represented, or whether any particular offset or correlation structure was used. General descriptions of the method should not be mistaken for confirmation of those choices in this trial.
How should the confidence interval be read?
The reported 95% confidence interval is 0.36 to 0.97. In general, a confidence interval describes the range of estimates compatible with the observed data and the assumptions of the method, at the stated confidence level. It conveys precision: a narrower interval would indicate more precision, while a wider interval would indicate less. The interval is not a guarantee that the true effect lies within its endpoints, and it does not describe the range of individual outcomes.
Because this is a ratio, the interval is interpreted relative to the null value for equal rates. Its endpoints indicate that the estimated relative rate could plausibly be closer to the null or farther from it, under the model. The interval does not show the absolute rate difference, and the registry does not report an absolute comparison with its own confidence interval.
What does the p-value add?
The reported p-value is 0.04. In general, a p-value describes how unusual data at least as incompatible with the null model as those observed would be, assuming the null model and analysis assumptions. It is not the probability that the null hypothesis is true, nor is it a measure of the size or clinical importance of the difference. A p-value should be read with the effect estimate, confidence interval, endpoint definition, and limitations of the analysis.
The registry record does not report whether the primary analysis was prespecified in a full analysis plan, whether there were interim analyses, or whether any multiplicity procedure was used. Although multiple outcomes are posted, the record does not explain how the primary p-value should be interpreted in relation to them. The p-value is thus the reported result of the stated regression analysis, not a complete account of the trial’s statistical decision process.
How do planning calculations differ from observed results?
General sample-size illustrations based on an observed effect are planning scenarios. They explore the participant requirements under stated assumptions, such as a significance level, allocation, and fraction of the observed effect to detect. Such illustrations are not the trial’s original design justification and are not observed power. The registry record does not report the trial’s sample-size justification. Any planning figures should not be read as evidence that the study had a particular probability of detecting the true effect after the trial was completed.
For this trial, the primary inferential result to interpret is the sponsor-reported negative binomial regression estimate and its confidence interval. The registry does not report enough model detail to reproduce that analysis independently. Methodological descriptions explain what the named approach generally does, but they do not fill in unreported protocol or analysis decisions.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Negative Binomial Regression | Incidence Rate Ratio 0.59 | 0.36 to 0.97 | 0.040 |
The registry reports the sponsor’s comparison as a negative binomial regression incidence rate ratio of 0.59, with a 95% confidence interval from 0.36 to 0.97 and p = 0.04. This is the posted inferential analysis for the primary endpoint. No separate recalculated two-arm estimate is reported in the registry record, so there is no independent recalculation to compare with the sponsor’s model result.
The arm-specific rates, 1.32 and 2.25 episodes per person-year at risk, are descriptive summaries. They do not replace the regression analysis, which is the stated method for comparing the groups. Reproducing a model-based estimate would require information about the underlying data and model specification that is not reported in the registry record.
The reported ratio and interval should therefore be read as the sponsor’s analysis as recorded, with its stated method and available uncertainty measure. The registry does not provide further information on covariate adjustment, model diagnostics, or analysis populations that would allow a fuller audit of the estimate.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists five secondary outcomes in addition to the primary malaria incidence-density outcome. They concern adverse events following antimalarial therapy, complicated malaria, first malaria episodes, recurrent parasitemia, and recurrent malaria. Multiple outcome analyses can raise a multiplicity question: when several hypotheses are assessed, the chance of at least one apparently unusual result may differ from what would be expected for a single prespecified test. In general, a study may address this with a prespecified hierarchy or adjustment, but the registry record does not report whether either approach was used.
The record does not report an analysis plan describing which outcomes or comparisons were designated as confirmatory, or how the primary p-value was to be interpreted alongside secondary results. It also does not report interim analyses or stopping rules. Without those details, the posted primary result can be described as the reported analysis, but its place in a broader testing strategy cannot be established from the registry.
Missing-data handling is not reported in the registry record. The record does not state how incomplete outcome observations, loss to follow-up, or missing covariates were handled, nor does it describe sensitivity analyses for missing data. The analysis population is also not reported in sufficient detail to determine whether the posted comparison followed an intention-to-treat, per-protocol, or other population definition.
These omissions do not establish that the trial lacked such procedures; they mean the registry record does not document them. They limit assessment of the assumptions behind the comparison and of how robust the result may be to missing information or alternative analysis choices.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Group 1 | 11 | 84 | 13.1% |
| Group 2 | 9 | 86 | 10.5% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Group 1 | 41 of 84 |
| Group 2 | 43 of 86 |
Most frequent serious adverse event terms
| Event term | Organ system | Group 1 | Group 2 |
|---|---|---|---|
| Neutropenia/Absolute neutrophil count | Blood and lymphatic system disorders | 7 of 84 | 9 of 86 |
| Dyspnea/respiratory distress | Respiratory, thoracic and mediastinal disorders | 4 of 84 | 3 of 86 |
| Anemia | Blood and lymphatic system disorders | 2 of 84 | 3 of 86 |
| Elevated ALT | Hepatobiliary disorders | 2 of 84 | 2 of 86 |
| Thrombocytopenia Platelets, decreased | Blood and lymphatic system disorders | 3 of 84 | 1 of 86 |
| Elevated Temperature/Fever | Endocrine disorders | 2 of 84 | 1 of 86 |
| Seizure | Nervous system disorders | 2 of 84 | 1 of 86 |
| Diarrhea | Gastrointestinal disorders | 1 of 84 | 1 of 86 |
| Vomiting | Gastrointestinal disorders | 1 of 84 | 1 of 86 |
| Altered mental status | Psychiatric disorders | 0 of 84 | 1 of 86 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Group 1 | Group 2 |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 24 of 84 | 21 of 86 |
| Elevated Temperature | Endocrine disorders | 19 of 84 | 24 of 86 |
| Thrombocytopenia Platelets, decreased | Blood and lymphatic system disorders | 9 of 84 | 6 of 86 |
| Anemia | Blood and lymphatic system disorders | 2 of 84 | 4 of 86 |
| Elevated ALT | Hepatobiliary disorders | 2 of 84 | 3 of 86 |
| WBC, decreased | Blood and lymphatic system disorders | 1 of 84 | 2 of 86 |
| Chills | Endocrine disorders | 2 of 84 | 0 of 86 |
| Elevated AST | Hepatobiliary disorders | 1 of 84 | 1 of 86 |
| Diarrhea | Gastrointestinal disorders | 0 of 84 | 1 of 86 |
| Pallor | Skin and subcutaneous tissue disorders | 0 of 84 | 1 of 86 |
Serious events with the highest arm-level rate: neutropenia/absolute neutrophil count (10.5%), dyspnea/respiratory distress (4.8%), thrombocytopenia platelets, decreased (3.6%), anemia (3.5%), elevated alt (2.4%).
The registry reports serious adverse events affecting 11 of 84 participants at risk in Group 1 and 9 of 86 in Group 2. For other adverse events, it reports 41 of 84 and 43 of 86, respectively. These are counts of participants with events in the registry’s categories; they are not the malaria incidence-density endpoint. Death counts are not reported in the registry record.
The listed serious adverse event terms and percentages include neutropenia/absolute neutrophil count, 10.5%; dyspnea/respiratory distress, 4.8%; thrombocytopenia/platelets decreased, 3.6%; anemia, 3.5%; elevated ALT, 2.4%; and elevated temperature/fever, 2.4%. The registry does not clarify in this summary how these term percentages relate to the two arms, whether events could be counted in more than one category, or how the terms were selected for listing. They should not be treated as arm-specific rates without that information.
In general, adverse-event counts need context about definitions, observation time, severity, and attribution. The registry does not report enough detail to determine whether the events were judged related to a study regimen or to compare exposure-adjusted safety rates. These figures describe the posted categories and counts; they do not establish that a regimen caused or prevented an event.
13. What the Result Does, and Does Not, Mean
The registry’s primary result is a comparison of malaria episode rates over time at risk. The arm-specific rates are 1.32 and 2.25 episodes per person-year at risk. The reported negative binomial regression incidence rate ratio is 0.59, with a 95% confidence interval from 0.36 to 0.97 and p = 0.04. Taken together, these figures indicate that the model estimated a lower malaria episode rate in the LPV/r-based arm than in the NVP- or EFV-based arm during the trial follow-up, while retaining uncertainty about the size of the relative difference.
This result does not give the probability that an individual child would experience malaria, and it does not directly quantify an absolute rate difference. It is not a result for every malaria-related outcome: the registry separately lists outcomes for complicated malaria, first malaria episodes, and recurrence. Nor is the primary endpoint a measure of treatment safety. The adverse-event summaries are separate and require their own definitions and context.
The result does not establish that either regimen will have the same relative rate in other populations or settings. It applies to the children enrolled in this Ugandan trial and the trial’s conditions and follow-up, as described in the registry. The record does not report sufficient participant characteristics, adherence information, or outcome-assessment procedures to assess how closely the trial population or conduct may match other settings.
Statistical evidence and clinical importance are different questions. The confidence interval and p-value characterize the reported statistical comparison under the model; they do not determine whether the size of the estimated difference is important to patients or clinicians. The registry does not report a threshold for clinical importance. The result should therefore be read as a model-based estimate of malaria incidence-density, with uncertainty and limits on what can be concluded from the registry record.
14. Why This Trial Matters Statistically
This trial presents a useful statistical example of an endpoint based on recurrent events. A participant may experience more than one malaria episode, so a simple count of participants with any episode would not capture all event burden. Incidence-density relates episode counts to time at risk, allowing the comparison to account for the amount of observation contributed by participants. This makes the endpoint distinct from the risk of a first episode, which is separately listed as a secondary outcome.
The registry also illustrates why an effect estimate should be read together with its uncertainty. The reported incidence rate ratio is 0.59, and its 95% confidence interval ranges from 0.36 to 0.97. The estimate offers a relative comparison, while the interval shows that the precise magnitude remains uncertain. The p-value of 0.04 adds information about the result under the model, but it does not replace the estimate or establish clinical importance.
Negative binomial regression is a relevant method to recognize when outcomes are counts and may show over-dispersion. However, naming the model is not enough to fully evaluate an analysis. Details about model specification, person-time, repeated events, missing observations, and analysis populations would support a more complete assessment; those details are not reported in the registry record.
Finally, the trial highlights the difference between a randomized design and a complete account of trial conduct. Randomization supports group comparison, while the open-label design and unreported information about outcome assessment and follow-up leave questions for interpretation. The registry result is informative as a posted model-based comparison, but its scope should remain tied to the endpoint, population, and documentation available.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record gives the endpoint name, unit, timeframe, arm rates, and reported regression result, but not the full endpoint definition. Operational details such as how malaria episodes were confirmed, how person-time at risk was calculated, and how recurrent episodes were handled are not reported in the registry record. These details are important for understanding a rate based on repeated events.
The trial was open label. The registry does not state whether outcome assessors or analysts were masked, or how outcome ascertainment was protected from knowledge of treatment assignment. It also does not report participant-level adherence, treatment changes, or how deviations from assigned regimens were handled. These omissions limit assessment of possible bias in the comparison.
Additional statistical details are not reported, including covariate adjustment, model diagnostics, the analysis population, missing-data methods, and sensitivity analyses. The registry also does not report a sample-size justification, interim analyses, or a multiplicity strategy. The posted negative binomial regression result cannot be fully audited from the summary information alone.
The registry lists adverse-event counts and selected serious adverse event terms, but does not provide enough detail to assess event attribution, exposure time, or the relationship between listed term percentages and treatment arms. Death counts are not reported in the registry record. These limitations apply to interpretation of the available safety summaries and should not be taken as evidence that the events did or did not differ between groups.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children — NCT00978068.
- Registry record last updated 2018-12-28; status last verified 2018-12.
- Results first posted 2018-12-28.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
The registry describes a completed, randomized, open-label, parallel-group Phase 3 trial of antiretroviral regimens in HIV-infected children in Uganda. The comparison was lopinavir/ritonavir plus 2 NRTIs versus nevirapine or efavirenz plus 2 NRTIs. The primary endpoint was malaria incidence-density in episodes per person-year at risk.
The arm-specific rates were 1.32 and 2.25. The reported negative binomial regression incidence rate ratio was 0.59, with a 95% confidence interval from 0.36 to 0.97 and p = 0.04. The registry also lists five secondary outcomes and adverse-event summaries. Important details about the analysis plan, model specification, missing data, and analysis population are not reported in the registry record.