Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir (NCT02097108), a na phase 2 study. The primary outcome is Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction.

2. Clinical Question

The clinical question is about change after a treatment-regimen switch, not about whether raltegravir performs better than another regimen. Participants continued their background therapy, which the registry says was to remain the same. The specified primary timeframe is baseline to week 12, while the study description gives a 24-week duration. Secondary outcomes listed in the registry compare total cholesterol, triglycerides, and HDL cholesterol at baseline and after 24 weeks.

The endpoint combines several possible indicators of improvement, including changes in LDL cholesterol, total cholesterol, and lipid-lowering treatment. That definition matters when interpreting the question: a participant could meet the stated criterion through one of these pathways. The registry does not report how many participants met each pathway, the total number meeting the combined definition, or the corresponding confidence interval. It therefore does not allow a numerical estimate of the proportion meeting the primary endpoint.

3. Trial Design

NCT02097108 is a completed phase 2 interventional study of changes in lipids and lipoproteins among HIV-infected women with hyperlipidemia. The registry describes it as a multicenter, one-arm, open-label, non-comparative study. It records an enrollment of 11 participants. There was no randomized allocation and no masking; the registry identifies the model as a single group.

Participants were offered a switch from a protease inhibitor-containing regimen to a raltegravir-based regimen. The recorded dose was raltegravir 400mg twice daily, taken orally, while maintaining the same background therapy. Because everyone was in a single treatment group, the design can describe within-group changes over time, but it does not supply a concurrent control group for separating treatment-associated changes from other changes that occur over time.

The primary outcome timeframe was baseline to week 12. The study description says the intervention was evaluated over 24 weeks. The three listed secondary outcomes concern total cholesterol, triglycerides, and HDL cholesterol, each assessed at baseline and after 24 weeks. Four outcome measures are recorded in total, but the registry does not report numerical results for these outcomes in the information available in the record.

The study status is completed. The recorded start was 2014-05 and primary completion was 2015-12. The sponsor is Arbeitsgemeinschaft medikamentoese Tumortherapie. A detailed protocol, eligibility criteria beyond the described population, adherence information, and the statistical analysis plan are not reported in the registry record. The record also does not describe the rationale for the enrollment target, whether recruitment stopped as planned, or whether any deviations from the intended treatment or follow-up occurred.

With no randomized comparison, differences between baseline and follow-up are not equivalent to a controlled treatment effect. A within-group change may reflect the switch, but it may also reflect other influences, natural variation, changes in care, or measurement variability. The study design is suited to describing changes in this small group; by itself, it cannot establish how those changes compare with what would have happened without the switch.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: all patients

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.

6. Primary Endpoint

The registry lists the primary outcome as Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction, measured over baseline to week 12.

The primary endpoint is listed as the number, expressed as a percentage of participants, with low-density lipoprotein cholesterol reduction. Its timeframe is baseline to week 12, and the registry identifies a 95% confidence interval as the measure of dispersion. The endpoint description defines a qualifying change as a reduction of > 5% in plasma direct LDL cholesterol, or a reduction of > 10% in total cholesterol, or a reduction in lipid-lowering agents because lipid profiles improved. A decrease in lipid-lowering agents due to side effects or other toxicity is expressly excluded from that last pathway.

This type of endpoint turns several possible changes into a participant-level classification: whether a person meets the stated criterion or does not. In general, such a proportion can make a clinical threshold easier to interpret than a collection of continuous laboratory values, while losing information about the size and distribution of individual changes. The combined definition also means that knowing the overall proportion alone would not show which criterion participants met.

The endpoint is relevant to the study’s focus on lipid profiles after switching regimens, but the registry does not report the observed number or percentage meeting it. The stated 95% confidence interval is also not reported as a numerical result. The endpoint’s population is described as all patients; the number actually included in its analysis is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a participant-level percentage endpoint and identifies a 95% confidence interval for it. It does not name the confidence-interval method, statistical test, model, or analysis population in more detail than all patients. The numerical estimate and interval are not reported in the registry record. Accordingly, statistical concepts can clarify what such an analysis would generally represent, but they should not be mistaken for a description of methods confirmed to have been used in this study.

What does a participant percentage represent?

In general, a participant percentage is formed by counting people who meet a defined criterion relative to the number of people assessed. In this study’s endpoint, the criterion combines a specified direct LDL cholesterol reduction, a specified total cholesterol reduction, or a qualifying reduction in lipid-lowering agents. The endpoint therefore classifies participants according to whether they satisfy at least one of the described routes to improvement. The record does not provide the observed count, the denominator analyzed, or separate counts for the individual routes.

As a general statistical matter, the denominator is essential: a percentage has meaning only alongside the number of participants assessed and the number meeting the criterion. The enrollment count is not necessarily the analyzed denominator, since participants may lack a measurement or may not meet the analysis conditions. The registry does not state how many participants had usable data at week 12 or how missing endpoint data were treated.

What does a confidence interval add?

In general, a confidence interval conveys uncertainty around an estimate. For a participant percentage, it reflects the fact that an observed proportion from a limited group may differ from the proportion that would be seen in a broader population under similar conditions. Its width depends on the amount and pattern of information and on the calculation method. A confidence interval is not a guarantee that the true value lies within a particular reported interval, and it does not account automatically for design limitations such as the absence of a control group.

The registry specifies a 95% confidence interval for the primary measure, but the interval itself and the method used to calculate it are not reported in the registry record. Thus, no numerical statement about statistical precision can be made. In particular, the 11 enrolled participants should not be substituted for an analysis denominator unless the endpoint data confirm that all 11 were assessed.

How should baseline-to-follow-up measures be understood?

The primary timeframe compares baseline with week 12, while the listed secondary lipid outcomes compare baseline with week 24. In general, a within-person comparison uses paired measurements to characterize change in the same participants. A group-level summary of such changes can describe what happened over time in the group, but without a separate comparison group it cannot isolate the effect of the regimen switch from time trends, concurrent care, measurement variation, or other influences.

The record does not specify whether the continuous lipid outcomes were analyzed as raw follow-up values, changes from baseline, or adjusted changes. It also does not report summary measures, variability measures, tests, or confidence intervals for these secondary outcomes. Therefore, a particular analysis method should not be attributed to the study based only on the outcome labels.

Why does over-dispersion matter in general?

In general, over-dispersion occurs when observed variability is greater than a statistical model assumes. For count or proportion data, an overly restrictive model can make uncertainty appear smaller than it is. Possible approaches depend on the data structure and model, and should be specified in an analysis plan. The registry record does not report an over-dispersion assessment or a model for the primary endpoint. With no outcome estimate or analysis details recorded, it is not possible to assess whether over-dispersion was relevant or how it was handled.

What can the study design establish?

In general, a single-group before-and-after study can describe observed changes among participants who receive the intervention. A concurrent randomized comparison is ordinarily more informative for distinguishing treatment effects from changes that might have occurred over time for other reasons. This study is explicitly non-comparative, with no allocation to a control group. That feature limits causal interpretation regardless of the statistical method used to summarize the measurements.

The registry lists no analyses. This means inferential results and analysis details are not reported in the registry record; it does not establish what analyses may have been conducted outside the record. The record does not report prespecified covariate adjustment, interim analyses, handling of outliers, or sensitivity analyses. Those elements should not be assumed.

What would a planning calculation mean?

In general, a sample-size calculation is a planning exercise based on assumptions about a target effect, variability or event frequency, significance level, and desired power. It is not an observed study result and does not show the probability that a particular finding is true. The registry’s planning description refers to an illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; for non-time-to-event outcomes, the stated convention is participants per arm. However, no numerical planning estimates are reported in the registry record, and the actual trial had one group rather than two allocated arms. Such an illustration cannot be read as the trial’s observed power or as evidence that the design had adequate precision.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Raltegravir")
n      <- c(11)
events <- c(10)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Raltegravir  11  10  90.9  58.7  99.8  62.3  98.4  61.5  97.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures: the primary lipid-improvement measure and secondary measures for total cholesterol, triglycerides, and HDL cholesterol. It does not report a hierarchy among these measures beyond identifying one as primary, nor does it report a multiplicity adjustment, a family-wise error strategy, or another approach for interpreting multiple outcome tests. The statistical analysis plan is not reported in the registry record. Because there are no numerical efficacy analyses reported, it is not possible to assess how multiple outcomes were analyzed or interpreted.

Missing-data handling is also not reported. The record does not state how many participants contributed baseline, week-12, or week-24 data; whether any participants discontinued or missed visits; or whether imputation, complete-case analysis, or another approach was used. The primary endpoint population is described as all patients, but that label does not establish the analysis denominator or explain how unavailable measurements were treated.

In general, missing measurements can affect both the estimated outcome and its uncertainty, particularly if the likelihood of missingness is related to participants’ health or observed values. Likewise, multiplicity matters because assessing several outcomes can increase the chance of at least one apparently unusual result when many tests are performed. These are general statistical considerations, not evidence that either issue occurred or was addressed in this study. Without analysis details and posted results, the registry record does not permit a judgment about the impact of missingness or multiplicity.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: abdominal pain (9.1%).

The safety record lists 11 participants at risk for serious adverse events and 1 participant affected. For other adverse events, it lists 11 at risk and 5 affected. These figures describe the recorded participant counts; they do not establish that raltegravir caused an event. The registry does not report an attribution assessment or comparative safety group.

Abdominal pain is listed among the leading serious adverse-event terms, with a reported value of 9.1%. The record does not provide additional detail about the event’s timing, clinical course, relationship to treatment, or whether the participant had more than one event. A term’s appearance in a serious-event listing should not be interpreted as a causal finding.

The registry record does not report a death count. It also does not provide event-level descriptions, duration of follow-up for safety, or detailed definitions for the other adverse-event category. The counts should therefore be read as a limited registry summary rather than a complete account of safety experience. Since the study enrolled 11 participants and did not include a comparison group, these figures alone cannot establish whether the observed events were more or less frequent than they would have been under another regimen.

13. What the Result Does, and Does Not, Mean

The record describes a small, single-group study of HIV-infected women with hyperlipidemia who switched from a boosted protease inhibitor regimen to raltegravir while continuing their background therapy. It identifies a primary endpoint for lipid improvement between baseline and week 12, and secondary lipid measures at week 24. Those design details establish what the study set out to assess; they do not establish the size or direction of the observed changes.

The primary outcome result is not reported in the registry record. Neither the number or percentage of participants meeting the endpoint nor its 95% confidence interval is available. Numerical results for the secondary lipid outcomes are also not reported. Therefore, the registry record cannot support a quantitative account of lipid changes or their precision. It also cannot show whether participants met the endpoint through the LDL criterion, the total cholesterol criterion, or a qualifying reduction in lipid-lowering agents.

Even if before-and-after results were available, the non-comparative design would limit conclusions about cause. Observed changes could be associated with the switch, but changes over time may also reflect other factors. A concurrent comparison group would be needed to directly compare outcomes under alternative treatment strategies; this study did not include one.

The record does document selected safety counts: one participant affected by a serious adverse event and five affected by other adverse events, each among 11 at risk in the respective category. Abdominal pain is listed at 9.1% among the leading serious-event terms. These summaries do not establish treatment causation, and the record does not report a death count.

In general, a completed study status means the registry lists the trial as completed; it does not mean every planned result is posted or that a definitive conclusion can be drawn. The evidence described in this record is limited by missing outcome results, small enrollment, lack of a comparator, and unreported analysis and missing-data details. It is best interpreted as a record of the study’s question and design, alongside a limited safety summary, rather than a complete statistical report of its lipid outcomes.

14. Why This Trial Matters Statistically

This study raises a useful statistical question about how lipid changes are summarized after a regimen switch in a defined population. Its endpoint is not a single laboratory value: it combines direct LDL cholesterol change, total cholesterol change, and a qualifying reduction in lipid-lowering agents. Such a composite definition may capture multiple forms of improvement, but it also makes separate reporting important. Without the number of participants meeting each criterion, readers cannot tell which component drives an overall result.

The design also illustrates the distinction between observing change and estimating a comparative treatment effect. In a single-group study, baseline and follow-up measurements can describe the experience of participants who switched regimens. They cannot directly show how those changes compare with outcomes under a different strategy. This distinction remains important even when a study has a prespecified endpoint and a confidence interval.

Precision matters especially in small studies. In general, limited participant information can result in considerable uncertainty around a proportion or mean change. The registry identifies 11 enrolled participants, but does not report the primary endpoint estimate, its confidence interval, or the endpoint denominator. Readers therefore cannot evaluate the precision of the primary outcome or determine how much information the analysis contains.

The record also demonstrates why transparent reporting of analysis populations, missing-data methods, outcome results, and uncertainty measures is necessary for statistical interpretation. These details are not reported in the registry record. In their absence, the study’s stated aims and safety counts can be described, but the lipid findings cannot be quantitatively assessed or compared with a clear inferential framework.

Statistically, the most important lesson is to keep the scope of a result aligned with the design and reporting. A within-group change is descriptive unless supported by a suitable comparative analysis, and a stated confidence-interval plan is not a substitute for the interval itself. The registry record leaves those central efficacy details unavailable.

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 principal limitation for interpretation is that the registry record does not report the primary endpoint result or its 95% confidence interval. It also does not provide numerical results for the listed secondary lipid outcomes. Without observed estimates, readers cannot assess the direction, magnitude, or precision of lipid changes.

The study enrolled 11 participants and had one open-label group. The lack of a concurrent comparator prevents a direct assessment of how outcomes would differ under another regimen. Open-label treatment can also influence behavior, co-interventions, and assessments, although the registry does not report whether any such effects occurred in this study.

The primary endpoint has multiple routes to meeting its definition. Separate results for LDL cholesterol reduction, total cholesterol reduction, and qualifying changes in lipid-lowering agents are not reported. The record also does not report endpoint denominators, participant-level missingness, attrition, adherence, or how missing measurements were handled. As a result, the completeness and composition of the analyzed data cannot be evaluated.

Further limitations include the absence of a posted statistical analysis plan, inferential analysis details, or multiplicity strategy in the registry record. The record does not state how the confidence interval was calculated, whether estimates were adjusted, or whether sensitivity analyses were performed. It also does not report detailed safety attribution or a death count. These omissions constrain interpretation of both efficacy and safety, without demonstrating that any specific problem occurred.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir — NCT02097108.
• Registry record last updated 2016-09-13; status last verified 2016-07.
• Results first posted 2016-09-13.
• 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.

19. Record Summary

NCT02097108 is a completed phase 2, multicenter, open-label, single-group, non-comparative study of a regimen switch in HIV-infected women with hyperlipidemia. The registry records 11 participants and describes switching from a boosted protease inhibitor regimen to raltegravir 400mg twice daily while maintaining background therapy.

The primary endpoint concerns a participant-level lipid-improvement definition from baseline to week 12. Secondary outcomes include total cholesterol, triglycerides, and HDL cholesterol at baseline and week 24. The numerical primary and secondary results, the primary confidence interval, and analysis details are not reported in the registry record.

The safety summary records 1 participant with a serious adverse event and 5 with other adverse events, among 11 at risk for each category. Abdominal pain is listed at 9.1% among the leading serious-event terms. With no comparison group and no posted efficacy estimates, the record supports a description of the trial design and selected safety counts, but not a quantitative conclusion about lipid changes.