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 Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma (NCT01625169), a na na study. The primary outcome is Peak Plasma Concentration of Etravirine in Plasma.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01625169 |
| Phase | NA |
| Condition | HIV |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 9 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Southern California |
| Results posted | Yes |
2. Clinical Question
Population
HIV-positive pregnant women receiving highly active antiretroviral therapy, described in the record as postpartum participants for the pharmacokinetic assessment. The study enrollment is 9. The record notes that one participant did not complete the Day 5 evaluation.
Intervention
Etravirine 200mg PO BID for 14 days, with pharmacokinetic assessments on days 5 and 14. The study description focuses on measuring etravirine concentrations in plasma and breast milk.
Comparator
There is no comparator group. The registry describes a single-group study and lists allocation as NA, so the record does not support a like-for-like treatment comparison.
Primary question
What is the peak plasma concentration of etravirine on Day 5? The stated primary endpoint is a continuous pharmacokinetic measure. The study summary also describes an interest in drug penetration into breast milk and HIV viral load in breast milk and plasma, but those are not the listed primary endpoint.
The broader rationale in the registry concerns HIV viral load in breast milk and the potential relevance of etravirine concentrations to viral load. The listed endpoint, however, measures drug concentration in plasma, not HIV viral load or transmission. Breast-milk and plasma viral-load assessments appear among the secondary outcomes, but their numerical findings are not reported in the registry record. As a result, the primary question that can be identified from the record is pharmacokinetic: the level of etravirine measured at the specified time, rather than whether treatment changes clinical outcomes or transmission.
3. Trial Design
The registry describes a completed, single-group study sponsored by the University of Southern California. It lists an enrollment of 9 and gives the condition as HIV. Allocation is listed as NA, masking as none, and phase as NA. This is not a randomized comparison, and the study has no listed control arm. Consequently, it can describe measurements collected in the treated group but cannot, on its own, estimate a contrast against an untreated or differently treated group.
The intervention description specifies etravirine 200mg PO BID for 14 days, with pharmacokinetic assessments on days 5 and 14. The arm description identifies the participants as HIV-positive pregnant women and describes pharmacokinetics in breast milk and plasma. The registry's primary endpoint is peak plasma concentration on Day 5. It notes that one participant did not complete the Day 5 evaluation. The registry record does not state how the missing Day 5 assessment was handled in the primary analysis.
The listed study dates are a start in 2010-04 and primary completion in 2012-12; the status is completed. These dates indicate the timing recorded for the study, but do not provide details about recruitment pace, follow-up beyond the specified assessments, or whether the study ended according to its original schedule. Those details are not reported in the registry record.
The record lists 10 outcome measures and repeats the title “HIV Viral Load in Breast Milk and Plasma” among the secondary outcomes. It lists no analyses. The record does not report a sample-size justification, a protocol-level statistical analysis plan, or an interim-analysis plan. The enrollment is therefore descriptive of the registered study and should not be interpreted as evidence about the precision or power of its endpoint estimates.
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.
Overall Study
| Stage | HIV + Pregnant Women |
|---|---|
| STARTED | 9 |
| COMPLETED | 9 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Note: One participant did not complete the Day 5 evaluation.
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 | HIV + Pregnant Women |
|---|---|---|
| Participants analysed | 9 | |
| Age, Continuous | years | 28.1 (21 to 38) |
| Sex: Female, Male: Female | Participants | 9 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: United States | participants | 9 |
| Previous Pregnancies: Gravida | pregnancies | 3 (1 to 8) |
| Previous Pregnancies: Parity | pregnancies | 2 (0 to 6) |
| Previous Pregnancies: Abortion | pregnancies | 1 (0 to 3) |
| Type of Delivery: C-section | participants | 2 |
| Type of Delivery: Vaginal | participants | 7 |
| Timing of Delivery: Term | number participants | 8 |
| Timing of Delivery: Preterm | number participants | 1 |
| Previous Breast Feeding: Yes | participants | 1 |
| Previous Breast Feeding: No | participants | 7 |
| Absolute CD4 at Delivery | cells/ml | 437 (157 to 913) |
6. Primary Endpoint
The registry lists the primary outcome as Peak Plasma Concentration of Etravirine in Plasma, measured over Day 5.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | ng/ml |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is “Peak Plasma Concentration of Etravirine in Plasma,” expressed in ng/ml, with a Day 5 timeframe. Peak concentration, often called Cmax, is a pharmacokinetic measure describing the highest measured drug concentration over a defined assessment period. It helps characterize systemic drug exposure. The registry identifies the summary measure as a mean and the measure of dispersion as a standard deviation.
As a general statistical explanation, a mean gives a central summary of observed concentrations, while a standard deviation describes how much individual measurements vary around that mean. These summaries can convey both the typical measured concentration and the spread of concentrations in the assessed group. They do not, by themselves, indicate how accurately a treatment effect has been estimated, and they do not establish a comparison with another regimen or with no treatment.
The endpoint is relevant to the study’s stated pharmacokinetic aim of measuring etravirine in plasma and breast milk. It is not itself a measure of breast-milk drug concentration, HIV viral load, or HIV transmission. Although the registry’s rationale connects drug concentrations with interest in breast-milk viral load, the primary endpoint remains a plasma concentration on Day 5. The numerical mean and standard deviation for that endpoint are not reported in the registry record, so its observed level and variability cannot be described from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies a focused pharmacokinetic question: the peak plasma concentration of etravirine on Day 5 among participants in a single treated group. It specifies the measure, unit, summary statistic, dispersion statistic, and assessment time. It does not give the observed mean or standard deviation. Without those endpoint results, the magnitude and variability of the measured plasma concentrations cannot be assessed from the registry record.
The study enrollment is 9, and the primary endpoint description notes that one participant did not complete the Day 5 evaluation. That missing assessment matters because the primary outcome is tied specifically to Day 5. The record does not report the number of participants included in the endpoint analysis, how missing data were handled, or whether the analysis used any imputation or other adjustment. The enrollment figure should therefore not be treated as the endpoint analysis denominator.
The single-group design is important for interpretation. With no control group, the record does not establish what plasma concentrations would have been under a different regimen or without etravirine. It also does not allow a randomized estimate of a treatment effect. A concentration estimate, if reported, would describe observations in this group under the recorded regimen and assessment schedule. It would not by itself show that etravirine caused a change in concentration relative to another treatment.
The registry describes breast-milk and plasma HIV viral load as secondary outcome topics and gives a rationale involving breast-milk drug penetration and viral load. However, numerical secondary-outcome results are not reported in the registry record. Nor does the primary endpoint directly measure viral suppression, transmission, or an infant outcome. Those distinctions keep the interpretation aligned with the measured endpoint instead of extending it to outcomes the endpoint cannot answer.
The completion status and recorded dates describe the study’s registry status, not the strength of its findings. The record does not report an inferential result, confidence interval, or statistical test for the primary endpoint. Accordingly, it is not possible to judge statistical precision or the compatibility of the estimate with a range of values from the registry record alone. The result should be understood as unavailable in this record, rather than as a null finding or evidence that no effect occurred.
9. Statistical Methods Explained
The registry defines the primary outcome as a continuous measure: peak plasma concentration of etravirine in ng/ml on Day 5. It lists the mean as the summary parameter and standard deviation as the dispersion measure. These choices describe how a set of concentration observations may be summarized; they do not constitute a complete analysis plan. The observed mean and standard deviation are not reported in the registry record.
What does a mean summarize?
As a general statistical explanation, the mean is a measure of the center of a collection of numeric observations. For a pharmacokinetic endpoint, it can summarize the average concentration among the observations included in the analysis. Its interpretation depends on which participants had measurements and how those measurements were collected. The registry notes a missed Day 5 evaluation but does not state the analysis population or the handling of that missing value. It is therefore not possible to determine from the record exactly which observations contributed to the reported mean, because the mean itself is not reported.
What does the standard deviation describe?
As a general statistical explanation, the standard deviation describes the spread of observations around their mean. A smaller standard deviation corresponds to measurements that are more clustered around the mean; a larger one corresponds to more dispersion. It is a description of variability among observed measurements, not a confidence interval for the mean and not a measure of treatment benefit. Since neither the observed standard deviation nor the mean is reported, the degree of between-participant concentration variability cannot be evaluated from the registry record.
How would a confidence interval help?
As a general statistical explanation, a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the analysis. For a mean, it can help readers distinguish the point estimate from the range of values that remain compatible with the data and method. The registry record does not report a confidence interval for the primary endpoint. It also does not provide the ingredients needed to reconstruct one, including the observed endpoint summary and analysis denominator. A confidence interval should not be inferred from enrollment alone.
Why does the design affect the statistical question?
The study is listed as single-group, with allocation NA and masking none. As a general statistical explanation, a single-group design can describe observed outcomes in the group studied, but it does not provide a concurrent randomized comparator. It therefore cannot separate a treatment-related change from other possible explanations for an observed measurement. This limitation applies even if a concentration summary is available: the summary would characterize the group and schedule, rather than estimate a randomized contrast.
The sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is a stated fraction of the observed effect. The record does not report the calculated illustration values. These assumptions do not describe the actual design, which is single-group, and planning sample sizes are not observed power. The registry does not report that these assumptions were used to design or analyze the study. The study’s own sample-size justification is not reported in the registry record.
What can be concluded from the analysis information?
The registry lists 10 outcome measures but no analyses. It does not report a statistical test, model, adjustment strategy, confidence interval, or prespecified analysis population for the primary outcome. It also does not report whether assumptions for any inferential procedure were assessed. These absences mean that readers cannot evaluate the reported inferential method for the primary endpoint from this record.
As a general statistical explanation, over-dispersion refers to variability greater than a model expects. It can make standard errors too small and uncertainty look less than it is if the model does not account for the extra variability. This concept may be relevant to some count or event models, but the primary endpoint is a continuous concentration measure, and the registry does not report a model that would allow assessment of over-dispersion. It should not be presented as a demonstrated problem in this study.
Any recalculation from posted summary statistics would be an unadjusted recalculation, not a substitute for the sponsor’s own analysis where a discrepancy is identified. No recalculated primary endpoint result is reported in the registry record. In this case, the most important statistical constraint is the absence of the endpoint estimate and analysis details, alongside the explicitly noted incomplete Day 5 evaluation.
10. Confidence Intervals for Each Arm
No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.
| Arm | Participants | Mean | Standard deviation | 95% CI for the mean |
|---|---|---|---|---|
| HIV + Pregnant Women | 8 | 497.600 | 261.770 | 278.755 to 716.445 |
R code and output
arm <- c("HIV + Pregnant Women")
n <- c(8)
m <- c(497.6)
sp <- c(261.77)
sd <- sp # posted standard deviations
for (i in seq_along(n)) {
se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}
CARM HIV + Pregnant Women 8 497.600 261.770 278.755 716.44511. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures and repeats “HIV Viral Load in Breast Milk and Plasma” among the secondary outcomes. The record lists no analyses and does not report a multiplicity strategy, such as a hierarchy of outcomes or an adjustment for testing several outcomes. Whether such a strategy existed in the protocol is not reported in the registry record. Without analysis results and a stated plan, the risk of interpreting selected findings among multiple outcomes cannot be assessed from this record.
The primary endpoint description states that one participant did not complete the Day 5 evaluation. The registry does not report why the assessment was not completed, whether the participant had any other measurements, or how the missing value was handled. It also does not provide the primary analysis denominator or describe an analysis population. The enrollment of 9 is not necessarily the number contributing to the Day 5 endpoint, so it should not be substituted for an analysis denominator.
As a general statistical explanation, missing outcome data can affect both the precision and interpretation of an estimate. The direction and extent of any effect depend on why measurements are missing and on the method used to handle them. The record does not provide enough information to determine whether the missing assessment could have altered the endpoint summary. It also does not report sensitivity analyses or a plan for assessing the influence of missing data.
The registry record does not report interim analyses, an imputation approach, or a prespecified statistical analysis plan. Those items should be treated as unreported rather than assumed absent from the conduct of the study. The available information supports noting the incomplete Day 5 evaluation, but not inferring how it was treated analytically.
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 |
|---|---|---|---|
| HIV + Pregnant Women | 0 | 9 | 0.0% |
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 |
|---|---|
| HIV + Pregnant Women | 6 of 9 |
Most frequent non-serious adverse event terms
| Event term | Organ system | HIV + Pregnant Women |
|---|---|---|
| Breast Tenderness | Skin and subcutaneous tissue disorders | 6 of 9 |
| Diarrhea | Gastrointestinal disorders | 1 of 9 |
| Headache | Nervous system disorders | 1 of 9 |
The registry lists 9 participants at risk in the serious adverse-event category and 0 affected. It lists no serious adverse-event terms among the top serious terms. In the other adverse-event category, 9 were at risk and 6 were affected. The record does not provide event descriptions for that other category in the information.
These figures describe participants marked as affected in the listed categories; they should not be read as counts of individual events unless the registry specifies that interpretation. The record does not provide severity, timing, attribution to etravirine, or a comparison group for these figures. They therefore do not establish whether an event was caused by treatment or how the observed counts compare with another regimen.
The deaths entry is null, so a death count is not reported in the registry record. A null entry should not be interpreted as zero deaths. The same caution applies to any safety detail that is not listed: absence of a reported value is not evidence that no event occurred. The safety information supports only a limited description of the recorded affected counts and does not provide a comparative safety estimate.
13. What the Result Does, and Does Not, Mean
The record describes a completed, single-group pharmacokinetic study of etravirine in plasma and breast milk among HIV-positive pregnant women receiving antiretroviral therapy. The specified regimen is etravirine 200mg PO BID for 14 days, with pharmacokinetic assessments on days 5 and 14. The primary outcome is peak plasma concentration on Day 5, summarized as a mean with standard deviation.
The numerical result for that primary outcome is not reported in the registry record. Therefore, the record does not show the observed peak plasma concentration, its variability, or the precision of an estimate. It also does not report numerical findings for the secondary breast-milk and plasma viral-load outcomes. The stated scientific interest in breast-milk drug penetration and viral load is a rationale, not a substitute for those results.
The design does not include a comparator. It cannot establish that etravirine produced a particular concentration difference relative to another regimen, nor can it isolate a treatment effect from other influences. The primary endpoint is a drug concentration, not a direct measure of HIV transmission, infant infection, or clinical benefit. The registry’s background discussion of transmission does not make transmission an outcome demonstrated by the listed endpoint.
The missing Day 5 evaluation further limits interpretation because the registry does not describe the analysis denominator or missing-data method. The listed enrollment should not be treated as the number analyzed for the primary endpoint. In addition, no confidence interval or inferential analysis is reported, so precision cannot be judged.
These limitations do not imply that the study found no effect or that the intervention is ineffective. They define what can be established from this registry record: the study question, design, endpoint specification, and a limited set of safety counts. Claims beyond those details—including a quantitative pharmacokinetic conclusion or a transmission conclusion—are not supported by the outcome information reported in the record.
14. Why This Trial Matters Statistically
This study illustrates the distinction between a pharmacokinetic endpoint and a clinical outcome. Plasma peak concentration measures drug exposure in the body, while breast-milk concentration and viral load are separate measurements, and transmission is a further clinical outcome. The registry’s rationale connects these topics, but each requires its own measurement and analysis. Keeping them distinct prevents a concentration endpoint from being interpreted as direct evidence about viral suppression or transmission.
The single-group design also highlights why a clear question about estimation matters. Descriptive summaries can characterize concentrations within the studied group, but a treatment comparison requires a suitable comparator. With no comparator listed, the study’s design is aligned with describing pharmacokinetic measurements, not estimating a randomized treatment contrast.
The Day 5 completion note is statistically relevant even though the record does not report the endpoint result. Missing outcome information affects the interpretation of the analysis population and its precision. Reporting the number analyzed, the approach to missing values, and the endpoint estimate would help readers understand how the observed data support a conclusion. Those details are not reported in the registry record.
Finally, the registry lists multiple outcome measures while providing no analyses. This makes it important to distinguish the prespecified primary question from the broader outcome interests and to know how multiplicity was addressed. The record does not report that approach. These are general considerations for interpreting studies with several outcomes; they are not evidence that a particular analytic problem occurred in this study.
Overall, the study is statistically informative in its stated aim and endpoint structure, but the registry record does not supply the numerical primary result needed to judge the observed concentration or its precision. That gap limits quantitative interpretation without turning the missing result into a negative finding.
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 most direct limitation for interpreting the primary endpoint is that its numerical mean and standard deviation are not reported in the registry record. No confidence interval, analysis denominator, or test result is listed either. This prevents assessment of the observed Day 5 peak concentration and its precision.
The record notes that one participant did not complete the Day 5 evaluation but does not describe the reason, how the missing assessment was handled, or whether the participant contributed to other outcomes. It does not identify a primary analysis population. The enrollment figure alone cannot resolve these questions.
The single-group design has no comparator, so it cannot provide a randomized estimate of a contrast with another treatment or with no treatment. The absence of masking is recorded, but the registry does not describe how this could have affected measurement or conduct. The allocation field is NA, consistent with the record’s single-group description.
The registry lists 10 outcome measures but no analyses and repeats the secondary-outcome title concerning HIV viral load in breast milk and plasma. It does not report how multiple outcomes were handled, whether outcomes were prioritized beyond the listed primary endpoint, or whether a statistical analysis plan specified the analyses. The sample-size justification and interim-analysis plan are also not reported in the registry record.
The listed primary endpoint is a plasma concentration, not breast-milk concentration, HIV viral load, or transmission. While the study rationale discusses those related topics, numerical results for the secondary outcomes are not reported in the registry record. Safety information is also limited: the death count is not reported, and the adverse-event figures do not include details about event timing, severity, or attribution.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma — NCT01625169.
- Registry record last updated 2014-08-13; status last verified 2014-08.
- Results first posted 2014-08-07.
- 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.
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19. Record Summary
NCT01625169 is a completed, single-group study sponsored by the University of Southern California. The record lists enrollment of 9, phase NA, allocation NA, and masking none. It records a start in 2010-04 and primary completion in 2012-12.
The intervention is etravirine 200mg PO BID for 14 days, with pharmacokinetic assessments on days 5 and 14. The primary endpoint is peak plasma concentration of etravirine on Day 5, measured in ng/ml and summarized using a mean and standard deviation. The record notes that one participant did not complete the Day 5 evaluation.
The record lists 10 outcome measures and no analyses. Numerical results for the primary endpoint and the listed secondary viral-load outcomes are not reported in the registry record. Safety figures list 0 of 9 affected in the serious adverse-event category and 6 of 9 affected in the other category; the death count is not reported.