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 Angiotensin Receptors and Age Related Mitochondrial Decline in HIV Patients (NCT02606279), a randomized na study. The primary outcome is Change From Baseline in 400m Walk.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02606279 |
| Phase | NA |
| Condition | HIV, Aging, Sarcopenia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Wake Forest University Health Sciences |
| Results posted | Yes |
2. Clinical Question
Population
The study was designed for people with HIV. The arm descriptions specify HIV-infected participants. The registry record reports enrollment of 1, while the descriptions of both arms refer to 20 participants in each planned arm.
Intervention
The intervention was valsartan. Participants assigned to that arm were to take 40 mg by mouth daily for 2 weeks, then 80 mg by mouth daily for the remaining 22 weeks.
Comparator
The comparator was placebo for 24 weeks. The placebo arm was described as undergoing the same study procedures as the intervention arm.
Primary question
The primary outcome was change from baseline in time to finish a 400-meter walk, with assessments planned at 3, 6, and 9 months post-enrollment. The registry record says visits were not completed and data were not collected, so it does not provide a treatment comparison for this outcome.
3. Trial Design
The registry record describes a randomized, parallel-group study with quadruple masking. The study compared valsartan with placebo in people with HIV and was sponsored by Wake Forest University Health Sciences. Its listed phase is NA, and its status is terminated.
The arm descriptions specify 24 weeks of blinded therapy. The valsartan regimen was 40 mg by mouth daily for 2 weeks, followed by 80 mg by mouth daily for the remaining 22 weeks. Participants in the placebo arm were to receive placebo for 24 weeks and undergo the same study procedures as participants in the intervention arm. The registry record does not explain which participant roles were included in the quadruple masking.
The study began in 2014-07, and the primary completion date is listed as 2016-08-04. Although the arm descriptions refer to 20 participants in each arm, the reported enrollment is 1. These entries describe different aspects of the record: the arm descriptions set out the planned groups, while the enrollment figure reports the study's recorded enrollment.
The primary outcome was change from baseline in time to finish a 400-meter walk. The listed assessment times were 3, 6, and 9 months post-enrollment. Change from baseline in frailty status is listed as a secondary outcome. The registry record reports four outcome measures but no analyses, and it states that the participant did not complete visits and data were not collected.
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 | Placebo Control | Valsartan |
|---|---|---|
| STARTED | 0 | 1 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 0 | 1 |
Reasons for not completing this period:
| Reason | Placebo Control | Valsartan |
|---|---|---|
| Lost to Follow-up | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Participant did not complete visits, data not collected.
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: Gender, Race, and Ethnicity info not released due to confidentiality issues in this small sample of n=1
| Characteristic | Unit | Placebo Control | Valsartan | Total |
|---|---|---|---|---|
| Participants analysed | 0 | 1 | 1 | |
| Age, Categorical: <=18 years | Participants | — | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | — | 1 | 1 |
| Age, Categorical: >=65 years | Participants | — | 0 | 0 |
| Sex/Gender, Customized: Male | Participants | — | 0 | 0 |
| Sex/Gender, Customized: Female | Participants | — | 0 | 0 |
| Sex/Gender, Customized: Prefers not to identify | Participants | — | 1 | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | — | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | — | 0 | 0 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | — | 1 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | — | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | — | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | — | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | — | 0 | 0 |
| Race (NIH/OMB): White | Participants | — | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | — | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | — | 1 | 1 |
| Region of Enrollment: United States | participants | — | 1 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in 400m Walk, measured over 3, 6, and 9 months post-enrollment.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change from baseline in time to finish a 400-meter walk. It represents a timed walking assessment, with the measurement described as time to finish the distance. The registry record lists assessments at 3, 6, and 9 months post-enrollment.
General: A timed walk can serve as a functional measure because it records how long a participant takes to complete a standardized distance. Looking at change from baseline is intended to describe how the measure changes relative to the participant's starting value, rather than relying only on a later measurement. The endpoint can therefore be used to compare patterns of change between randomized groups when data are collected and analyzed.
In this study, however, the registry record says that the participant did not complete visits and that data were not collected. No baseline or follow-up walk times, change estimates, or comparison between groups are reported. The endpoint's planned measurement and rationale can be described, but the posted record does not show whether the groups differed on it.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive point is that the registry record does not contain a primary-outcome result. It identifies change from baseline in 400-meter walk time as the primary outcome and lists assessment times of 3, 6, and 9 months post-enrollment. It also says that the participant did not complete visits and data were not collected. Consequently, there is no reported change estimate, treatment contrast, confidence interval, or significance test for the walk outcome.
Enrollment is reported as 1. The arm descriptions refer to 20 HIV-infected participants in the placebo arm and 20 in the valsartan arm, but those descriptions do not establish that those planned numbers were enrolled or analyzed. The recorded enrollment figure is the available enrollment statistic. It is important not to interpret the arm descriptions as observed group sizes.
The registry record lists four outcome measures and zero analyses. It names change from baseline in frailty status as a secondary outcome, but it provides no numerical result for that outcome in the registry record. No treatment effect, direction of change, or precision estimate can be extracted from these entries.
For safety, the record lists zero participants at risk in the placebo group and 1 in the valsartan group for the displayed serious and other adverse-event counts. It records zero affected participants in each of those categories and zero deaths in both groups. These counts are limited by the very small reported enrollment and by the absence of an at-risk participant in the placebo group. They do not establish comparative safety or rule out events.
General: An effect estimate describes the size and direction of a contrast, while a confidence interval describes the range of values compatible with the observed data under the analysis assumptions. Neither can be interpreted when the outcome data and analysis are absent. A p-value alone would not replace an effect estimate or its uncertainty; in this record, no p-value is reported either.
The study status is terminated. The reason for termination and any decision-making process connected with it are not reported in the registry record. The record does not support a conclusion about whether valsartan changed walking performance, frailty, mitochondrial function, or any other clinical outcome.
9. Statistical Methods Explained
Randomization, masking, outcome definition, and analysis are different parts of a trial's statistical design. The registry record identifies random allocation, quadruple masking, and a parallel-group model. It does not describe the randomization procedure, how allocation was concealed, or which roles were masked. Those details are not reported in the registry record.
What does randomization contribute?
General: Randomization assigns participants to groups by chance. When implemented as planned, it helps make treatment groups comparable with respect to both measured and unmeasured characteristics in expectation. It does not guarantee balance in a small enrolled sample, and it cannot compensate for outcome data that were never collected. Here, the registry record reports enrollment of 1, so it offers no basis for assessing baseline balance or estimating a reliable treatment contrast.
What does masking mean?
The record labels the study quadruple-masked. General: Masking can limit the influence of knowledge about group assignment on participants' reports, study procedures, outcome assessment, or other trial processes. The exact people masked and the procedures used to maintain masking are not reported in the registry record, so the label should not be expanded into unsupported details.
How is the primary outcome defined?
The primary outcome is change from baseline in 400-meter walk time, measured as time to finish the walk. The record gives assessment times of 3, 6, and 9 months post-enrollment. General: A change-from-baseline outcome compares a follow-up measurement with a starting measurement. A group comparison would need collected measurements and an analysis specifying how those repeated observations were handled. The registry record provides neither an outcome dataset nor an analysis result.
What can be said about the analysis plan?
The registry record reports zero analyses. It does not report a statistical analysis plan, the model intended for the primary outcome, covariate adjustments, a method for handling repeated measurements, or an approach to missing outcome data. The sample-size justification and any interim analyses are not reported in the registry record. These omissions mean that the planned inferential procedure cannot be reconstructed from the available entries.
General: An analysis plan ordinarily defines the treatment contrast, outcome scale, analysis population, assumptions, and method for quantifying uncertainty. For repeated assessments, it may also explain whether each visit is analyzed separately or whether observations are modeled together. The choice can affect how a result is interpreted. Without a reported plan or collected data, it is not possible to evaluate whether assumptions were met or whether the analysis matched the intended question.
How should uncertainty be understood?
General: A point estimate gives a single estimate of an effect, whereas a confidence interval communicates uncertainty around that estimate under specified assumptions. With no reported primary-outcome values or analysis, neither a point estimate nor a confidence interval is available. The absence of a reported result is not evidence that the groups had identical outcomes; it means the record does not allow their difference to be estimated.
General: Over-dispersion occurs when the observed variability is greater than a statistical model expects. If present, it can make standard errors too small when ignored, which in turn can make uncertainty appear less than it is. The registry record provides no outcome data or fitted model from which over-dispersion could be assessed, and it does not report whether this issue was considered.
The study's arm descriptions give the intended treatment period and regimen, but planned allocation is not the same as analyzed exposure. The record does not report adherence, treatment discontinuation, protocol deviations, or actual treatment received. These are not available for assessing how closely the intervention was delivered as described.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary outcome, change from baseline in 400-meter walk time, at 3, 6, and 9 months post-enrollment. It also lists change from baseline in frailty status as a secondary outcome and reports four outcome measures overall. No analyses are reported. The record does not specify which visit was intended as the primary comparison, whether the assessment times were to be treated as separate tests, or how multiplicity across outcomes or times would be addressed. Those details are not reported in the registry record.
General: Multiplicity arises when several outcomes, time points, or comparisons are examined. Testing many contrasts can increase the chance of obtaining an apparently notable result by chance if no adjustment or prespecified hierarchy is used. A prespecified analysis plan helps readers understand which comparisons were confirmatory and how multiple tests were handled. The record does not report such a plan, so no multiplicity procedure can be assessed.
For missing data, the registry record states that the participant did not complete visits and data were not collected. It does not report a missing-data method, reasons for missed visits, or whether any outcome data were available from other sources. The analysis population is also not reported in the registry record. General: Missing-data methods rely on assumptions about why measurements are absent; different assumptions can lead to different estimates. With no reported outcome data or analysis, the consequences of missingness cannot be evaluated.
The record's enrollment of 1 and zero reported analyses are especially important context for reading the outcome entries: there is no reported analyzed population from which to infer a treatment effect.
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 |
|---|---|---|---|
| Valsartan | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo Control | 0 of 0 |
| Valsartan | 0 of 1 |
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 |
|---|---|
| Placebo Control | 0 of 0 |
| Valsartan | 0 of 1 |
The registry record lists safety counts separately for the placebo control and valsartan groups. For placebo, the at-risk count is 0; for valsartan, it is 1. The serious adverse-event counts are 0 affected participants in both groups. The other adverse-event counts are also 0 affected participants in both groups, and the death count is 0 in each group. No serious adverse-event terms are listed.
These are counts, not comparative risk estimates. The placebo at-risk count of 0 means the record does not provide an exposed placebo participant denominator for interpreting the displayed event counts. The valsartan at-risk count of 1 is also too limited to characterize event frequency reliably. Zero recorded events in these entries should not be read as proof that an intervention cannot cause adverse events or as evidence of equivalent safety between groups.
General: Safety counts are most informative when the number of participants exposed, the length of exposure, event definitions, and completeness of reporting are understood. The registry record does not provide a basis for broader comparative safety conclusions. The listed counts should be read as the events recorded for the reported at-risk populations, not as a guarantee that no events occurred outside those entries.
12. What the Result Does, and Does Not, Mean
The study was designed to examine whether valsartan, compared with placebo, was associated with change in 400-meter walk time among people with HIV. The primary measure was time to finish a 400-meter walk, assessed at 3, 6, and 9 months post-enrollment. The record also lists change from baseline in frailty status as a secondary outcome.
What the record establishes is limited to the study's design and recorded status: it was randomized, quadruple-masked, parallel-group, and terminated; reported enrollment was 1; and no analyses are listed. The registry entry says the participant did not complete visits and data were not collected. It therefore contains no primary-outcome result from which to describe the direction, size, or precision of a valsartan-placebo difference.
These limitations do not show that the treatment groups were the same, nor do they establish that valsartan changed walking time or frailty. They indicate that the posted record does not report the observations and analyses needed to answer those questions. The arm descriptions of 20 participants in each group are descriptions of the planned arms and should not be mistaken for the recorded enrollment or for analyzed sample sizes.
The safety entries list zero affected participants and zero deaths, but the recorded at-risk counts are 0 for placebo and 1 for valsartan. Those figures do not support a dependable comparison between groups or a broad conclusion about safety.
General: A trial's scientific question and its ability to answer that question are distinct. A clear endpoint and randomized design can set out a comparison, but interpretation still depends on collecting the planned measurements and reporting an analysis with its uncertainty. In this record, the design is described, while the outcome comparison is not available. Conclusions about physical function, frailty, mitochondrial decline, or treatment effects cannot be drawn from the missing results.
13. Why This Trial Matters Statistically
This trial is statistically relevant because it illustrates the difference between a planned randomized comparison and an informative result. The record describes randomization, masking, parallel arms, a treatment schedule, and a primary functional outcome. Yet the reported enrollment is 1, no analyses are listed, and the record states that visits were not completed and data were not collected.
Those details shape what statistical interpretation is possible. Without outcome observations, there can be no reported treatment-effect estimate or measure of its precision. The absence of an estimate is not a null finding: it does not show that valsartan and placebo produced the same change. Nor can a planned arm description be treated as evidence that the planned participants were enrolled or analyzed.
The study also highlights why outcome timing and missing-data reporting matter. The primary endpoint had assessments planned at 3, 6, and 9 months post-enrollment, but the record does not report measurements at those times or an analysis specifying how they would be combined. It lists a secondary frailty outcome and four outcome measures overall, while giving no analyses or multiplicity approach.
The safety entries likewise show the importance of denominators and exposure context. The recorded at-risk counts are 0 for placebo and 1 for valsartan, which leaves little basis for comparing the groups. These entries are descriptive counts, not a robust comparative safety analysis.
For clinical researchers and biostatisticians, the record is a reminder to distinguish registration details, planned procedures, enrollment, collected outcomes, and analysis. Each contributes different evidence. Here, the available information supports describing the intended study and its reporting gaps, but not estimating treatment effects.
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 principal trial-specific limitation is that the primary outcome was not collected according to the registry description: the participant did not complete visits, and data were not collected. There is no reported walk time, change from baseline, treatment contrast, or uncertainty estimate. The registry record also reports enrollment of 1, despite arm descriptions referring to 20 participants in each planned group.
The study is listed as terminated, but the reason for termination is not reported in the registry record. The record does not explain the discrepancy between the planned arm descriptions and recorded enrollment, so no explanation should be inferred. It also does not report whether any participants began treatment or completed the assigned regimen.
The primary outcome has multiple listed assessment times, but the registry record does not specify how those measurements would be analyzed or which time point would define the main contrast. The secondary frailty outcome and the total of four outcome measures are listed without reported analyses. The analysis population, missing-data strategy, multiplicity plan, and statistical analysis plan are not reported in the registry record.
The safety counts have very limited denominators: 0 at risk in placebo and 1 in valsartan. The counts of affected participants and deaths are all zero, but these entries cannot establish comparative safety. The record does not report exposure duration by participant, adherence, or further safety context.
Finally, the registry record does not provide outcome data on mitochondrial function, muscle strength, or cellular decline, despite describing these topics in the study summary. The available entries therefore cannot establish findings about those biological or functional questions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Angiotensin Receptors and Age Related Mitochondrial Decline in HIV Patients — NCT02606279.
- Registry record last updated 2018-08-28; status last verified 2018-07.
- Results first posted 2017-12-05.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record identifies a randomized, quadruple-masked, parallel-group study sponsored by Wake Forest University Health Sciences, with status listed as terminated and phase listed as NA. It compared valsartan with placebo in people with HIV. The arm descriptions specify 24 weeks of treatment; the valsartan regimen was 40 mg by mouth daily for 2 weeks, followed by 80 mg daily for the remaining 22 weeks.
The primary outcome was change from baseline in time to finish a 400-meter walk, with assessments listed at 3, 6, and 9 months post-enrollment. Change from baseline in frailty status was listed as a secondary outcome. The record reports enrollment of 1, four outcome measures, and zero analyses. It states that the participant did not complete visits and data were not collected. No primary-outcome estimate or treatment comparison is reported.
The record lists zero affected participants and zero deaths in the displayed safety categories, with at-risk counts of 0 for placebo and 1 for valsartan. These limited counts do not permit a meaningful comparative safety conclusion.