Indication assessment · §3
HIV-associated lipodystrophy and excess visceral adiposity — trial records
Trial records in the Institute's register bearing on hiv-associated lipodystrophy and excess visceral adiposity.
§3Trials in this indication
11 trial records in the Institute's register bear on this indication, of which 2 are published trials.
Table 2. Trial records bearing on hiv-associated lipodystrophy and excess visceral adiposity.
| Record | Compound | Phase | Design | Randomised | Year |
|---|---|---|---|---|---|
| TESA-PIVOTAL-1 | Tesamorelin | Phase 3 | Randomised, double-blind, placebo-controlled | 412 | 2010 |
| TESA-PIVOTAL-2 | Tesamorelin | Phase 3 | Randomised, double-blind, placebo-controlled | 404 | 2010 |
| TESA-PIVOTAL-1-DDIprogramme record | Tesamorelin | Phase 1 | Randomised crossover | — | 2010 |
| TESA-PIVOTAL-2-PKprogramme record | Tesamorelin | Phase 1 | Phase 1 ascending dose | — | 2010 |
| TESA-PIVOTAL-1-HEPATIC-IMPprogramme record | Tesamorelin | Phase 1 | Phase 1 ascending dose | — | 2010 |
| TESA-PIVOTAL-2-RENAL-IMPprogramme record | Tesamorelin | Phase 1 | Phase 1 ascending dose | — | 2010 |
| TESA-PIVOTAL-1-RENAL-IMPprogramme record | Tesamorelin | Phase 1 | Phase 1 ascending dose | — | 2010 |
| TESA-PIVOTAL-2-HEPATIC-IMPprogramme record | Tesamorelin | Phase 1 | Phase 1 ascending dose | — | 2010 |
| TESA-PIVOTAL-1-PKprogramme record | Tesamorelin | Phase 1 | Phase 1 ascending dose | — | 2010 |
| TESA-PIVOTAL-2-DDIprogramme record | Tesamorelin | Phase 1 | Randomised crossover | — | 2010 |
| TESA-PIVOTAL-1-QOLprogramme record | Tesamorelin | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2010 |
| This facet in the trial register. | |||||
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. Metabolic effects of a growth hormone-releasing factor in patients with HIV. New England Journal of Medicine 2007;357(23):2359–2370. doi:10.1056/NEJMoa072375 · PMID 18052660
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.
Compound Evidence Institute · CEI-IN-20/3 · https://compoundevidence.com/indications/lipodystrophy/trials/ · retrieved 30 July 2026