The Effect on Lipid Profile of Switching to Delstrigo in HIV Positive Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Effect on Lipid Profile of Switching to Delstrigo in HIV Positive Patients (NCT05289986), a randomized phase 4 study. The primary outcome is To Quantify the Effect on Lipid Profile.

2. Clinical Question

The study’s broader hypothesis concerned possible effects of switching on lipid metabolism, glucose, weight, body composition and hepatic steatosis. Those topics describe the rationale and planned scope; they are not results. The primary endpoint focused specifically on total fasting cholesterol rather than combining the broader set of outcomes into a single measure.

Randomization was intended to make the assigned groups comparable, on average, for a comparison of the switching strategies. However, random allocation cannot overcome the lack of endpoint observations needed for an informative estimate. With only two participants reaching Week 24, the registry does not establish the size or precision of a difference in cholesterol change between the strategies.

3. Trial Design

NCT05289986 was a Phase 4, randomized, open-label, parallel-group study sponsored by Chelsea and Westminster NHS Foundation Trust. The registry lists enrollment as 19 and the study status as terminated. The recorded study start was 2023-11-21 and the recorded primary completion date was 2024-11-21. The registry does not explain how those dates relate to the early termination.

The planned comparison had an immediate-switch arm and a delayed-switch arm. The brief summary describes randomization in a 1:1 allocation, with N=30 specified for each planned arm. Participants assigned to immediate switching were to take TDF/3TC/DOR for 48 weeks. Participants assigned to delayed switching were to continue their existing regimen for 24 weeks and then switch to TDF/3TC/DOR for weeks 24–48. The listed enrollment of 19 is not the same as the planned arm counts; the registry does not reconcile these figures or provide a complete account of allocation.

The study was not masked. Participants and study personnel therefore were not kept unaware of the assigned switching strategy. This matters when considering outcomes that may involve participant reports or clinical decisions, although the primary endpoint was a laboratory measure. The record does not provide enough detail to assess procedures for laboratory measurement or whether outcome assessors were masked.

The record states that the trial was terminated early because of a sponsor decision and limited enrollment. It also reports that only two participants, one per arm, reached the Week 24 primary endpoint, preventing meaningful analysis. No participants completed the study fo—this wording is incomplete in the registry record and cannot be interpreted further. The available information therefore describes the intended design more fully than the study’s completed conduct or results.

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: Please see recruitment details.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.

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 To Quantify the Effect on Lipid Profile, measured over 24 weeks.

The primary endpoint was the change from baseline in total fasting cholesterol at Week 24. It was intended to quantify the lipid-profile effect of switching from a stable suppressive regimen to TDF/3TC/DOR, compared with remaining on the existing regimen over the same initial period. The endpoint is a change measure: it relates a participant’s Week 24 measurement to that participant’s baseline measurement, rather than describing a single cholesterol value in isolation.

Total fasting cholesterol is used as a measure of blood lipids. A change-from-baseline endpoint can help focus a comparison on how measurements shift during follow-up, while accounting for the starting value in each participant’s outcome. In a randomized trial, comparing change between assigned groups is intended to estimate the difference associated with the assigned strategies, subject to the conduct of the trial and the assumptions of the analysis.

The registry lists the timeframe as 24 weeks and describes the population as people with HIV on suppressive, stable cART containing the specified regimens. It does not report a numerical endpoint result, a group-level change, a between-group estimate, or a measure of uncertainty. The registry states that two participants, one per arm, reached this endpoint and that participant numbers were insufficient for statistical analysis. Therefore, the planned endpoint is clear, but its comparative effect cannot be estimated meaningfully from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical concepts can clarify what the planned analysis would have needed to show, but they cannot replace missing endpoint data. The registry identifies a randomized comparison and a change-from-baseline primary endpoint. It does not report a completed statistical analysis, a numerical treatment-effect estimate, or uncertainty around such an estimate. The explanations below are general and do not describe analyses that the registry confirms were performed.

What does randomization contribute?

Randomization assigns participants to strategies by chance. In general, this helps limit systematic differences between groups at the start of a trial, including differences that investigators may not have measured. It supports a comparison based on assigned strategy, provided the trial has sufficient outcome information and the analysis follows an appropriate plan. Randomization does not guarantee that groups will be balanced in every characteristic, especially when enrollment and endpoint information are very limited. The registry does not report a baseline comparison that would allow readers to assess the groups in this study.

Here, the stated allocation was 1:1, and the intended comparison was between immediate and delayed switching. The registry says only two participants reached the primary endpoint, one per arm. The design remains randomized, but the endpoint information is too limited for the record to give a meaningful estimate of the between-group difference.

What does change from baseline mean?

A change-from-baseline measure expresses how an outcome differs from a participant’s starting measurement at a specified follow-up. For this trial, the planned measure was the change in total fasting cholesterol by Week 24. A group comparison would ordinarily summarize the changes in each assigned arm and estimate how those summaries differ. That estimate would describe the observed data under the chosen analysis; it would not, by itself, show why the change occurred.

For a randomized comparison, an analysis might use the assigned group as the basis for comparison, but the registry does not report the analysis population or the method used for the primary endpoint. It also does not report participant-level or group-level cholesterol values. Consequently, no calculation of a treatment contrast can be reconstructed from the record.

What would a confidence interval tell a reader?

In general, a confidence interval describes the statistical uncertainty around an estimated effect under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates less precision. An interval can also show which effect sizes remain compatible with the data and analysis. It does not remove limitations in study conduct or turn a small amount of information into a definitive answer.

No confidence interval for the primary comparison is reported in the registry record. Given the stated endpoint count, the record provides no basis for describing the precision of a cholesterol effect estimate. It would be inappropriate to substitute a confidence interval or other estimate that is not reported.

What would a p-value contribute?

In general, a p-value measures how incompatible the observed data are with a specified null model, under the assumptions used for the test. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. A p-value also does not replace an effect estimate and its uncertainty. In this record, no primary-endpoint p-value is reported, and no primary comparison is listed among the analyses.

How should planning illustrations be read?

Sample-size calculations are planning tools. They describe how much information might be needed under stated assumptions to detect a chosen effect with a chosen statistical procedure. The registry’s stated illustration assumptions include a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect expressed as a stated fraction of the observed effect. Such calculations are not observed power and do not demonstrate that the trial had a particular probability of detecting an effect after the fact.

The trial record does not provide a meaningful primary-endpoint effect estimate from which to interpret a trial-specific observed effect. Therefore, planning illustrations should not be treated as evidence about the result of this trial. They cannot correct for early termination or create endpoint information that was not collected or reported.

Why does over-dispersion matter in general?

Over-dispersion is a general issue in statistical models for count data. It occurs when the variability in the observed counts is greater than the model expects. If ignored, a model can understate uncertainty and make results appear more precise than they are. The registry record does not report a count-model analysis for the primary lipid endpoint, and no such method should be inferred from the listed outcomes. The concept is relevant only as general statistical context, not as a description of an analysis performed in this study.

More broadly, a statistical method is interpretable only when its endpoint, analysis population, assumptions and results are sufficiently described. The record identifies the intended primary measure and the reason meaningful analysis was not possible, but it does not report the plan or output needed to evaluate an inferential analysis. That absence limits independent assessment of both the estimate and the approach that would have been used to obtain it.

10. Multiplicity, Missing Data and Analysis Populations

The study lists a primary lipid endpoint and a range of secondary outcomes, including treatment-related adverse events, body fat, waist circumference, insulin sensitivity, cellular lipid measures, adipocytokines, pituitary hormones and estimated cardiovascular risk. When a study evaluates multiple outcomes or time points, testing each can increase the chance of at least one apparently notable result arising by chance. Statistical approaches to address this issue may include prioritizing a primary endpoint, adjusting tests, or interpreting secondary findings as exploratory. These are general options, not methods confirmed for this trial.

The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or whether secondary analyses were intended to be confirmatory or exploratory. It also does not report interim analyses or a statistical analysis plan. Because the record lists no analyses and the primary endpoint could not be meaningfully analyzed, it is not possible to assess how multiplicity would have been handled in practice.

The record does not describe a missing-data method or explain how participants who did not reach Week 24 would have been handled in the primary analysis. It does not report the primary analysis population, such as whether analysis would follow assigned groups regardless of switching or treatment adherence. Those details are not reported in the registry record. The fact that only two participants reached the primary endpoint makes these omissions especially important for interpreting the intended comparison, but no missing-data procedure should be assumed.

In general, missing outcomes can affect both the amount of information available and the validity of an estimate if the reasons for missingness relate to outcomes or assigned groups. The record does not provide the reasons for individual participants’ missing endpoint measurements or enough detail to evaluate that possibility. Consequently, no adjustment for multiplicity, missing data, or analysis population can be attributed to the study.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent non-serious adverse event terms

The registry lists serious adverse event figures by arm. In the Immediate Switch Arm, 7 were listed at risk and 0 as affected by serious adverse events; in the Delayed Switch Arm, 6 were listed at risk and 0 as affected. The death count is 0 in each arm. The record lists no serious adverse event terms.

For other adverse events, the Immediate Switch Arm lists 7 at risk and 6 affected, while the Delayed Switch Arm lists 6 at risk and 3 affected. These are the registry’s reported counts. They should not be converted into percentages or interpreted as a treatment comparison without further information about event definitions, observation periods and analysis methods. The record does not state whether each affected participant had a single event or multiple events.

The secondary-outcome list refers to treatment-related adverse events by Week 48, but the group counts above are not themselves a reported comparative analysis of treatment-related events. The record does not explain event attribution, severity criteria beyond the serious/other categories, timing, or the relationship of these counts to the planned Week 48 outcome. Descriptive counts do not establish that a strategy caused or prevented an event, and the small amount of recorded information limits safety interpretation.

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

The record establishes that a randomized, open-label study was planned to compare an immediate switch to TDF/3TC/DOR with a delayed switch in people living with HIV on stable suppressive therapy. It also identifies the intended primary question: change from baseline in total fasting cholesterol at Week 24. These design details explain what the trial was set up to investigate.

The record does not provide a numerical primary outcome result. It states that the study was terminated early because of a sponsor decision and limited enrollment, and that only two participants, one per arm, reached the primary endpoint. It says those numbers prevented meaningful analysis. Therefore, the posted record cannot establish the magnitude, direction, or precision of a difference in cholesterol change between strategies.

This absence of an interpretable comparison is not evidence that the strategies produce equivalent lipid changes. It is also not evidence that one strategy produces a favorable or unfavorable change. The study’s hypothesis about lipid metabolism and other health measures is a statement of what investigators expected to examine, not a result. Likewise, listing secondary outcomes does not show that those outcomes were measured, analyzed or found to differ.

In general, a treatment-effect conclusion requires an estimate supported by adequate outcome information, along with an account of uncertainty and relevant analysis assumptions. The record lacks those elements for the primary endpoint. Its status as a randomized trial does not make the unreported comparison recoverable from the design description alone.

The most defensible interpretation is consequently narrow: the trial was intended to answer a comparative lipid question, but its reported primary-endpoint information was insufficient for a meaningful statistical answer. The record also does not support broader conclusions about the intervention’s effects on glucose, weight, body composition, hepatic steatosis, or safety. Those topics were within the stated scope, but their results are not reported in a form that permits conclusions.

13. Why This Trial Matters Statistically

This study illustrates a distinction that is important in clinical research: a well-defined question and randomized design are not enough to produce an informative result if too few participants contribute data to the primary endpoint. Randomization can support a fair comparison, but it does not guarantee precision. Here, the registry reports that only two participants reached Week 24, one in each arm, and explicitly states that meaningful analysis was not possible.

The record also shows why planned enrollment, listed enrollment and endpoint availability should not be treated as interchangeable. The brief summary specifies N=30 for each planned arm, while the registry lists enrollment as 19. It separately reports the small number reaching the primary endpoint. Those entries describe different aspects of the study, and the registry does not reconcile them. For statistical interpretation, the observations available for the endpoint are central to whether a comparative estimate can be made.

Early termination also affects what readers can learn. A trial that stops before its planned follow-up may leave the primary contrast and secondary questions unanswered. In this record, early termination is attributed to a sponsor decision and limited enrollment. The registry does not report a completed primary analysis that could clarify how much information was retained.

The case is useful for reading registry records cautiously. A protocol’s hypothesis, planned endpoints and intended allocation describe what investigators set out to study; they do not substitute for posted effect estimates. Similarly, safety counts and planning illustrations have different purposes from an analysis of the primary endpoint. Separating these elements helps prevent an absence of evidence from being mistaken for evidence of no effect, and prevents a hypothesis from being read as a finding.

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 main trial-specific limitation is that the primary endpoint was reached by only two participants, one per arm. The registry says participant numbers were insufficient for statistical analysis and that meaningful analysis was prevented. No numerical change in total fasting cholesterol or between-arm estimate is reported, so neither the size nor precision of the planned comparison can be assessed.

The study was terminated early because of a sponsor decision and limited enrollment. The record does not give further detail about the decision, the timing of termination relative to recruitment or follow-up, or how study conduct changed after termination. It lists enrollment as 19, while the brief summary describes planned arm counts of N=30 each; the registry does not explain the relationship between those figures or provide a complete account of participant flow.

Important analysis details are not reported in the registry record, including the statistical analysis plan, analysis population, method for handling missing primary outcomes, multiplicity approach and any interim analyses. Baseline characteristics and details relevant to evaluating group comparability are also not available in the listed details. These gaps prevent assessment of the intended or actual analysis beyond the registry’s statement that meaningful primary analysis was not possible.

The record lists secondary outcomes but does not provide numerical results for them. The adverse event counts are descriptive and lack further context about event definitions, timing and attribution. The registry’s primary endpoint description is therefore more informative about what was planned than about what was observed. These limitations mean the available record cannot support broad conclusions about lipid changes, other biological outcomes or comparative safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: The Effect on Lipid Profile of Switching to Delstrigo in HIV Positive Patients — NCT05289986.
• Registry record last updated 2026-05-28; status last verified 2026-05.
• Results first posted 2026-05-28.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT05289986 was a Phase 4, randomized, open-label, parallel-group switch study sponsored by Chelsea and Westminster NHS Foundation Trust. It examined an intended switch from stable suppressive cART to TDF/3TC/DOR in people living with HIV. The primary endpoint was change from baseline in total fasting cholesterol at Week 24.

The study was terminated early because of a sponsor decision and limited enrollment. The registry lists enrollment as 19 and reports that only two participants, one per arm, reached the primary endpoint. It states that the available numbers prevented meaningful analysis. No numerical primary-endpoint comparison is reported, and the record lists no analyses.

The registry describes planned immediate and delayed switching strategies and several secondary outcomes, but does not provide results that support conclusions about the primary lipid question or the broader outcomes. The safety counts are descriptive and are not a comparative analysis.