Change in Neurocognitive Performance
| Group | Value (Z-score) |
|---|---|
| Immediate Group | 0.146 |
| Deferred Group | 0.103 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons
NCT0257232315 Feb 2017 to 15 Oct 2023
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The aim of this study is to test whether tesamorelin, in combination with a text-messaging application to help with motivation and adherence, will significantly improve memory and thinking in HIV.
Active comparator
Immediate group
1.4mg of tesamorelin is injected once a day for 6 months, then no treatment is given for 6 months
Placebo comparator
Deferred group
No treatment is given for 6 months, then 1.4mg of tesamorelin is injected once a day for 6 months
Outcomes the sponsor listed as primary.
Change in Neurocognitive Performance
Time frame · Baseline and week 24
The primary outcome was neurocognitive (NC) change, measured by the summary regression-based change score (sRCS), derived from a comprehensive battery assessing seven NC domains using the Global Deficit Score (GDS). The sRCS is calculated as a z-score from regression model residuals between baseline and week 24, adjusting for practice effects, statistical artifacts, and demographics. Altogether, 15 individual z scores are computed, by dividing the difference between predicted (Xp) and obtained (Xo) follow-up scaled scores by the error term of the regression model (Xo-Xp/SD-residual) and then averaged to generate the sRCS. Scores center around 0 (no change), with negative scores indicating decline and positive scores improvement. Significant changes are defined by 90% confidence intervals (±1.645 SD) such that participants in the top 5% of the sRCS distribution of the normative, stable reference sample were defined as "improved," and the bottom 5% were defined the "decliners."
Insulin-like Growth Factor 1 (IGF-1)
Time frame · Baseline and week 24
Change in Insulin-like growth factor 1 (IGF-1), a biomarker of visceral adipose tissue (VAT)-related inflammation and immune activation, from baseline to week 24
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Z-score) |
|---|---|
| Immediate Group | 0.146 |
| Deferred Group | 0.103 |
| Group | Value (% increase in IGF-1 from week 0 to 24) |
|---|---|
| Immediate Group | 53.2 |
| Deferred Group | 5.3 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Immediate Group1.4mg of tesamorelin is injected once a day for 6 months, then no treatment is given for 6 months Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV | 0 / 43 | 2 / 43 | 37 / 43 |
| Deferred GroupNo treatment is given for 6 months, then 1.4mg of tesamorelin is injected once a day for 6 months Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV | 0 / 30 | 0 / 30 | 20 / 30 |
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