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 Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults (NCT00608569), a randomized na study. The primary outcome is Confirmed Virologic Failure at or Prior to Week 48.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00608569 |
| Phase | NA |
| Condition | HIV Infections |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 529 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
| Results posted | Yes |
2. Clinical Question
Population
Adults with HIV who had experienced their first virologic failure on a non-nucleoside reverse transcriptase inhibitor-containing regimen and were starting a protease inhibitor-based regimen at study entry. The primary-outcome description says 257 eligible participants were included in the intent-to-treat analysis. The record does not further describe participant characteristics or explain how eligibility was determined.
Intervention
Modified directly observed therapy, or mDOT, paired with the study treatment. The regimen was oral FTC/TDF plus LPV/rtv or TDF plus ZDV plus LPV/rtv for 52 weeks. Participants had mDOT for the first 24 weeks, then self-administered treatment for the remaining 28 weeks.
Comparator
Self-administration of the same listed treatment options for 52 weeks, without the mDOT period. Thus, the randomized contrast concerns the medication-taking support strategy and its timing, not a comparison of different listed drug regimens.
Primary question
Did the randomized groups differ in the number of participants with confirmed virologic failure at or prior to week 48? The registry defines the endpoint and the analysis population, but the primary outcome counts for either group are not reported in the registry record. The direction, size, and precision of any group difference therefore cannot be assessed from the primary outcome information recorded there.
3. Trial Design
The registry describes a randomized, parallel-group trial with no masking. The enrollment field reports 529 participants. The primary-outcome record separately states that 257 eligible participants were included in an intent-to-treat analysis; the registry record does not explain the relationship between these figures or give a participant-flow account. The listed condition is HIV infections, and the study is marked completed.
Both groups received an oral protease inhibitor-based regimen for 52 weeks. The listed options were FTC/TDF plus LPV/rtv or TDF plus ZDV plus LPV/rtv. In the mDOT group, trained-partner supervision applied during the first 24 weeks, followed by self-administration for the remaining 28 weeks. The comparison group self-administered the study treatment throughout the 52 weeks. The stated study purpose was to measure the effect of trained-partner supervision when taking medication in participants starting this second-line regimen.
The registry lists the study start as 2009-03 and primary completion as 2012-09. It records the phase as NA. No details about the randomization procedure, allocation concealment, stratification, or masking of outcome assessment are reported in the registry record. No protocol-specific rationale for the enrollment target or further explanation of the study’s design choices is reported either.
The primary endpoint was confirmed virologic failure at or prior to week 48. Secondary outcomes included confirmed failure at or prior to week 24, CD4 and CD8 counts at follow-up visits, time to first grade 3 or 4 laboratory event, time to first grade 3 or 4 sign or symptom, time to first such laboratory or clinical event, and adherence to the second-line regimen. The record lists eight outcome measures and one analysis, but does not provide further detail about how these measures were analyzed.
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: Five hundred twenty nine subjects including participants and partners entered the study. Among the 529 subjects, 259 were participants, which included two participants with eligibility violations. Only the 257 eligible participants were included in the analyses. All participants started TDF/FTC +LPV/rtv and stratified by screening HIV-1 RNA only.
Overall Study
| Stage | mDOT Arm | Non-mDOT Arm |
|---|---|---|
| STARTED | 129 | 128 |
| COMPLETED | 119 | 119 |
| NOT COMPLETED | 10 | 9 |
Reasons for not completing this period:
| Reason | mDOT Arm | Non-mDOT Arm |
|---|---|---|
| Death | 4 | 3 |
| Lost to Follow-up | 4 | 5 |
| Withdrawal by Subject | 1 | 0 |
| Adverse Event | 1 | 0 |
| Unable to adhere with study requirements | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed.
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.
Population: Five hundred twenty nine subjects including participants and partners entered the study. Among the 529 subjects, 259 were participants, which include two participants with eligibility violations. Only the 257 eligible participants were included in the analysis.
| Characteristic | Unit | mDOT Arm | Non-mDOT Arm | Total |
|---|---|---|---|---|
| Participants analysed | 129 | 128 | 257 | |
| Age, Categorical: <=18 years | Participants | 1 | 0 | 1 |
| Age, Categorical: Between 18 and 65 years | Participants | 127 | 123 | 250 |
| Age, Categorical: >=65 years | Participants | 1 | 5 | 6 |
| Age, Continuous | years | 39.3 (SD 9.7) | 39.4 (SD 10.6) | 39.4 (SD 10.1) |
| Sex: Female, Male: Female | Participants | 62 | 65 | 127 |
| Sex: Female, Male: Male | Participants | 67 | 63 | 130 |
| Race/Ethnicity, Customized: Black Non-Hispanic | participants | 101 | 103 | 204 |
| Race/Ethnicity, Customized: Hispanic (regardless of race) | participants | 27 | 25 | 52 |
| Race/Ethnicity, Customized: More than one race | participants | 1 | 0 | 1 |
| Region of Enrollment: Haiti | participants | 37 | 36 | 73 |
| Region of Enrollment: Zambia | participants | 4 | 5 | 9 |
| Region of Enrollment: Botswana | participants | 4 | 4 | 8 |
| Region of Enrollment: Peru | participants | 23 | 23 | 46 |
| Region of Enrollment: Uganda | participants | 25 | 25 | 50 |
| Region of Enrollment: South Africa | participants | 15 | 17 | 32 |
| Region of Enrollment: Zimbabwe | participants | 17 | 16 | 33 |
| Region of Enrollment: Brazil | participants | 4 | 2 | 6 |
| CD4 Counts | cells/mm3 | 164 (91 to 250) | 201 (97 to 292) | 179 (92 to 269) |
| CD4 Count Category: 0-50 cells/mm3 | participants | 17 | 14 | 31 |
| CD4 Count Category: 51-100 cells/mm3 | participants | 20 | 19 | 39 |
| CD4 Count Category: 101-200 cells/mm3 | participants | 40 | 31 | 71 |
| CD4 Count Category: 201-350 cells/mm3 | participants | 35 | 47 | 82 |
| CD4 Count Category: 351-500 cells/mm3 | participants | 9 | 12 | 21 |
| CD4 Count Category: >500 cells/mm3 | participants | 8 | 5 | 13 |
| Log10 HIV-1 RNA Viral Load | log10 copies/mL | 4.2 (3.8 to 4.9) | 4.3 (3.8 to 4.9) | 4.3 (3.8 to 4.9) |
| HIV-1 RNA Viral Load Category: <=400 copies/mL | participants | 6 | 5 | 11 |
| HIV-1 RNA Viral Load Category: 401-999 copies/mL | participants | 4 | 2 | 6 |
| HIV-1 RNA Viral Load Category: 1000-9999 copies/mL | participants | 42 | 38 | 80 |
| HIV-1 RNA Viral Load Category: 10000-99999 copies/mL | participants | 54 | 55 | 109 |
| HIV-1 RNA Viral Load Category: 100000-499999 copies/mL | participants | 17 | 24 | 41 |
| HIV-1 RNA Viral Load Category: >=500000 copies/mL | participants | 6 | 4 | 10 |
6. Primary Endpoint
The registry lists the primary outcome as Confirmed Virologic Failure at or Prior to Week 48, measured over At or prior to Week 48.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with confirmed virologic failure at or prior to week 48. The registry’s definition uses repeated HIV-1 RNA measurements: two successive measurements at least 24 hours apart must meet one of the specified criteria. These include insufficient decline from baseline and a measurement above 400 copies/mL at the week 12 evaluation, or a measurement above 400 copies/mL at or after the week 24 evaluation. The definition also classifies participants who discontinue follow-up for a reason other than study completion, including death, at or before 50 weeks after randomization as having virologic failure.
Using a virologic endpoint provides a measure of whether the regimen has achieved the specified viral-load criteria during follow-up. Requiring successive measurements can distinguish a confirmed event from an isolated measurement, while the discontinuation rule makes certain departures from follow-up count as failures under the registry definition. These are features of the endpoint definition, not evidence about how many participants experienced an event.
The primary outcome is described as a number of participants, and the registry says that counts for participants with or without failure were reported. However, the counts by group are not reported in the registry record. No effect estimate or confidence interval for the primary comparison is available in the recorded primary-outcome information, so the magnitude and precision of the group contrast cannot be described.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study was designed to compare two medication-taking strategies in a specific clinical context: adults with HIV beginning a protease inhibitor-based regimen after first virologic failure on an NNRTI-containing regimen. One group used modified directly observed therapy for the first 24 weeks and then self-administered treatment; the other self-administered treatment throughout the 52-week regimen. Because the study was randomized, its central comparison is between the groups as assigned, subject to the analysis and follow-up details. The registry describes the design as unmasked.
The primary endpoint is confirmed virologic failure at or prior to week 48. The registry includes a detailed endpoint definition, but it does not report the event counts in the groups. Consequently, there is no recorded primary-outcome contrast to interpret: the direction of the difference, its size, and its statistical precision are not available from this record. No conclusion about whether the strategies differed on this endpoint can be drawn from the primary outcome information recorded.
The enrollment field reports 529, while the primary-outcome description identifies 257 eligible participants in the intent-to-treat analysis. These figures refer to different registry entries, and the record does not explain the participant flow or why the analysis population is described in this way. The counts should not be treated as interchangeable. Without a flow account, it is not possible to assess from the record how enrollment, eligibility, exclusions, and analysis membership relate to one another.
The record lists secondary outcomes covering earlier confirmed virologic failure, CD4 and CD8 counts, grade 3 or 4 laboratory and clinical events, and adherence. Their presence identifies other questions the trial addressed, but the listed outcomes alone do not provide their numerical results. The registry record does not report enough information to determine which secondary comparisons were statistically significant or how they relate to the primary endpoint.
Serious and other adverse-event figures are recorded separately from the primary efficacy endpoint. They can describe reported event counts in the listed groups, but should not be read as a substitute for the missing primary outcome results. Overall, the registry gives useful design and endpoint definitions, yet leaves the main randomized comparison’s observed result and its uncertainty unreported.
9. Statistical Methods Explained
Randomization is intended to create groups that are comparable, on average, with respect to factors that could affect outcomes. This helps make a between-group comparison informative about the assigned strategies. It does not guarantee that every measured or unmeasured characteristic will be balanced in a particular trial. The registry identifies random allocation and a parallel-group design, but does not report the sequence-generation method, allocation concealment, or any stratification factors.
The trial is described as unmasked. In general, lack of masking can matter when knowledge of assignment influences participant behavior, treatment delivery, reporting, or outcome assessment. The primary endpoint is based on HIV-1 RNA measurements and defined follow-up rules, but the registry record does not say whether laboratory staff or those determining endpoint status were masked. It also does not provide enough information to evaluate how the open-label design was handled in the analysis.
The primary endpoint is a binary participant-level outcome: a participant either met the registry’s confirmed-failure definition by the stated follow-up point or did not. The registry says the outcome was reported as counts of participants experiencing or not experiencing failure. For a binary endpoint, a comparison could be presented using group-specific event proportions and an effect measure, such as a difference or ratio, together with uncertainty. Those are general ways to describe binary outcomes; the registry record does not report the primary group counts or an estimated effect, so no such values can be interpreted.
A confidence interval, in general, describes a range of effect values compatible with the observed data under a statistical model and its assumptions. It communicates precision as well as the direction and scale of an estimate. A narrow interval generally indicates greater precision than a wide interval, but interpretation also depends on the measure and the clinical question. The registry record does not report a confidence interval for the primary comparison. A p-value, which summarizes how surprising data would be under a specified null model, is also not reported for that comparison.
The outcome definition combines repeated laboratory measurements with a discontinuation rule. In general, the use of successive measurements can reduce reliance on a single potentially transient result. The additional rule classifying some discontinuations as failure affects what the endpoint means: it incorporates specified departures from follow-up into the outcome rather than treating every such case as an ordinary missing observation. The record does not state how other missing laboratory measurements, missed visits, or incomplete follow-up were handled.
Intent-to-treat analysis generally aims to compare participants according to their randomized assignments, regardless of later adherence or treatment changes. The registry describes the primary analysis as intent-to-treat, and states that 257 eligible participants were included. It does not explain how participants without endpoint data were handled, how eligibility affected inclusion, or whether any sensitivity analyses were performed. Those details are important for judging the consequences of incomplete follow-up or departures from assigned treatment.
The record lists one analysis and eight outcome measures. It does not report a statistical analysis plan, a named test or model for the primary endpoint, an adjustment strategy, or an interim-analysis plan. No particular method should therefore be attributed to the investigators beyond the stated intent-to-treat analysis. The absence of reported details does not establish that a method was not used; it means the method is not reported in the registry record.
The sample-size assumptions describe planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. Such illustrations are conditional calculations for planning and are not observed trial outcomes or observed power. The registry does not report a sample-size justification from the trial’s own design, so the illustration should not be treated as evidence about the original enrollment rationale or the trial’s achieved ability to detect an effect.
General statistical interpretation also depends on whether the chosen model matches the data and whether relevant assumptions are reasonable. For binary outcomes, the definition of the analysis population, outcome ascertainment, and handling of missing data can affect the estimate. No model diagnostics, assumption checks, or sensitivity analyses are reported in the registry record. Since the primary counts and analysis details are absent, the statistical precision and robustness of the primary comparison cannot be evaluated from the record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several outcome measures in addition to the primary endpoint, including virologic failure by an earlier follow-up point, CD4 and CD8 counts, time to grade 3 or 4 laboratory events, time to grade 3 or 4 signs or symptoms, combined laboratory or clinical events, and adherence. When multiple outcomes or repeated comparisons are examined, the chance of finding at least one apparently notable result can increase. General approaches to this issue include specifying a hierarchy of outcomes or adjusting inference across comparisons. The registry record does not report whether any multiplicity strategy was planned or used.
The record identifies the week 48 virologic-failure outcome as primary and describes one analysis, but it does not provide a statistical analysis plan explaining how the primary and secondary outcomes were prioritized. The number of listed outcomes alone does not establish that all were tested in the same way or that any particular correction was required. No adjustment method, decision rule, or interim-analysis procedure is reported in the registry record.
The primary analysis is described as intent-to-treat and includes 257 eligible participants. Missing-data handling is not reported in the registry record. In particular, the record does not state whether participants lacking a qualifying viral-load assessment were excluded from the endpoint analysis, classified by a specified rule, or addressed through an imputation or sensitivity analysis. The endpoint definition explicitly treats certain discontinuations as failures, but that rule does not explain how every other form of incomplete follow-up was handled.
The record also does not provide a participant-flow description that connects the enrollment figure of 529 with the 257 participants named in the primary-outcome population. Without that information, readers cannot determine from the registry entry how eligibility, follow-up, or analysis inclusion affected the observed comparison. These gaps limit assessment of multiplicity and missing-data risk; they do not establish what procedures were or were not used outside the registry record.
11. 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 |
|---|---|---|---|
| mDOT Arm | 6 | 129 | 4.7% |
| Non-mDOT Arm | 7 | 128 | 5.5% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| mDOT Arm | 94 of 129 |
| Non-mDOT Arm | 98 of 128 |
Most frequent serious adverse event terms
| Event term | Organ system | mDOT Arm | Non-mDOT Arm |
|---|---|---|---|
| Death | General disorders | 2 of 129 | 0 of 128 |
| Renal failure | Renal and urinary disorders | 2 of 129 | 0 of 128 |
| Diarrhoea | Gastrointestinal disorders | 0 of 129 | 1 of 128 |
| Pancreatitis | Gastrointestinal disorders | 0 of 129 | 1 of 128 |
| Bronchopneumonia | Infections and infestations | 0 of 129 | 1 of 128 |
| Dehydration | Metabolism and nutrition disorders | 0 of 129 | 1 of 128 |
| Diabetes mellitus | Metabolism and nutrition disorders | 1 of 129 | 0 of 128 |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 129 | 0 of 128 |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | 0 of 129 | 1 of 128 |
| Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | 0 of 129 | 1 of 128 |
Most frequent non-serious adverse event terms
| Event term | Organ system | mDOT Arm | Non-mDOT Arm |
|---|---|---|---|
| Neutrophil count decreased | Investigations | 40 of 129 | 48 of 128 |
| Blood sodium decreased | Investigations | 28 of 129 | 19 of 128 |
| White blood cell count decreased | Investigations | 24 of 129 | 21 of 128 |
| Diarrhoea | Gastrointestinal disorders | 16 of 129 | 18 of 128 |
| Cough | Respiratory, thoracic and mediastinal disorders | 13 of 129 | 15 of 128 |
| Aspartate aminotransferase increased | Investigations | 13 of 129 | 14 of 128 |
| Pyrexia | General disorders | 11 of 129 | 15 of 128 |
| Blood alkaline phosphatase increased | Investigations | 15 of 129 | 8 of 128 |
| Blood glucose increased | Investigations | 14 of 129 | 9 of 128 |
| Haemoglobin decreased | Investigations | 8 of 129 | 14 of 128 |
Serious events with the highest arm-level rate: death (1.6%), renal failure (1.6%), diarrhoea (0.8%), pancreatitis (0.8%), bronchopneumonia (0.8%).
The registry reports serious adverse events for the mDOT arm as 6 affected among 129 at risk, and for the non-mDOT arm as 7 affected among 128 at risk. It also reports other adverse events as 94 among 129 at risk in the mDOT arm and 98 among 128 at risk in the non-mDOT arm. These are counts attached to the registry’s event categories; they are not the primary virologic endpoint and should be interpreted separately from it.
The record lists serious adverse-event terms that include Death and Renal failure at 1.6% each, and Diarrhoea, Pancreatitis, Bronchopneumonia, and Dehydration at 0.8% each. The listed term percentages are not presented by randomized group in the registry record, so they do not establish a group-specific rate for any term. The deaths field for each group is not reported.
Adverse-event summaries describe events recorded under the registry’s categories and follow-up procedures. They do not, by themselves, establish that an event was caused by a treatment strategy or allow a complete comparison of safety. The registry record does not provide further detail on event definitions, severity breakdowns beyond the listed categories, exposure time, or how these safety counts were analyzed. No conclusion about comparative safety should be based on these figures alone.
12. What the Result Does, and Does Not, Mean
This trial addresses a focused comparison: a period of trained-partner supervision followed by self-administration versus self-administration throughout treatment, among adults starting a protease inhibitor-based regimen after first virologic failure on an NNRTI-containing regimen. The common treatment options and the timing of the supervision strategy are described in the registry. The randomized design makes the assigned strategies the basis for the intended comparison.
The registry record does not report the primary endpoint counts by group, an effect estimate, or a confidence interval. It therefore does not establish the direction or magnitude of the difference in confirmed virologic failure at or prior to week 48, nor how precisely any difference was estimated. The endpoint definition alone is not a trial result. The listed secondary outcomes and adverse-event summaries likewise do not fill in the missing primary comparison.
The result, if assessed using a complete trial report, would need to be interpreted in light of the analysis population, follow-up, endpoint ascertainment, missing-data procedures, and statistical methods. The registry identifies an intent-to-treat analysis of 257 eligible participants, while the enrollment field reports 529; it does not explain the relationship between those entries. That leaves an important limitation for understanding which participants contributed to the stated primary analysis.
The findings described in a registry entry should also be kept within the population and treatment context recorded for this study. The information does not support extending a conclusion to people with different treatment histories, regimens, or care settings. More fundamentally, because the primary outcome result is not reported in the registry record, no claim about benefit, lack of benefit, or equivalence between strategies can be made from these data alone. The record contributes design and endpoint information, but not the numerical primary result needed to judge the randomized contrast.
13. Why This Trial Matters Statistically
Statistically, the trial poses a clear strategy comparison while holding the listed regimen options and overall treatment duration constant: mDOT during the initial part of treatment followed by self-administration, versus self-administration throughout. This distinction matters because the treatment contrast is not simply between two drug combinations. It concerns the addition and timing of trained-partner supervision in a defined treatment setting.
The endpoint also illustrates how an outcome definition can shape interpretation. Confirmed virologic failure is based on repeated HIV-1 RNA measurements and includes a stated discontinuation rule. That definition determines which events count toward the primary outcome and should be understood before interpreting any eventual effect estimate. The registry gives those criteria, even though it does not give the group-specific result.
The record highlights the difference between design information and result information. Randomization, the analysis population, and the endpoint are documented, but the primary event counts and uncertainty are absent. Without those results, the trial’s main randomized comparison cannot be statistically characterized. This distinction is important for readers: a detailed endpoint definition does not substitute for an estimate, and an enrollment figure does not establish the precision of an outcome comparison.
Finally, the discrepancy in the kinds of population figures recorded—the enrollment field and the eligible intent-to-treat population—shows why participant flow and analysis definitions are essential to evaluating clinical-trial evidence. The registry record does not resolve that relationship or describe missing-data handling. These omissions limit assessment of how the analysis reflects the randomized population and how robust the result would be to alternative assumptions.
14. 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 most direct limitation for interpreting efficacy is that the registry record does not report the primary endpoint counts by group, an effect estimate, or a confidence interval. The trial’s main comparison therefore cannot be evaluated for direction, size, or precision from this record. Although the endpoint is defined in detail, the outcome definition does not reveal the observed result.
The registry reports enrollment of 529 and separately states that 257 eligible participants were included in the intent-to-treat analysis. It does not explain participant flow, the eligibility criteria used for this analysis, or the relationship between those figures. It also does not report how missing viral-load measurements or other incomplete follow-up were handled, apart from the specified rule for certain discontinuations.
The record describes the trial as randomized and unmasked but does not report the randomization procedure, allocation concealment, or masking of outcome assessment. It lists multiple secondary outcomes without reporting a multiplicity strategy, detailed statistical analysis plan, or named model for the primary comparison. These omissions prevent a full assessment of the analysis choices and their implications.
The safety information is also limited in detail: the record lists group-level serious and other adverse-event counts and selected serious-event terms, but does not report deaths by group or further information about event ascertainment and analysis. The results and limitations should therefore be understood as those of the registry record, not as a complete account of every trial procedure or finding.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults — NCT00608569.
- Registry record last updated 2018-10-12; status last verified 2018-09.
- Results first posted 2013-11-15.
- 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
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18. Record Summary
The registry describes a completed, randomized, parallel-group, unmasked trial in adults with HIV beginning a protease inhibitor-based regimen after first virologic failure on an NNRTI-containing regimen. One group received mDOT for the first 24 weeks, then self-administered treatment; the comparator self-administered treatment throughout the 52-week regimen. The enrollment field reports 529.
The primary endpoint was confirmed virologic failure at or prior to week 48. The record states that 257 eligible participants were included in an intent-to-treat analysis, but does not report the primary outcome counts by group or an effect estimate. It also does not explain the relationship between the enrollment and analysis-population figures. Secondary outcomes and adverse-event counts are listed, but further analysis details, missing-data procedures, and a multiplicity strategy are not reported in the registry record.