Phase 2 N=39 Randomized Treatment

Raltegravir Therapy for Women With HIV and Fat Accumulation

HIV Infections · Lipodystrophy

Bottom Line

View on ClinicalTrials.gov: NCT00656175 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2012

Primary outcome: Primary: Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2) — -6.6; 1.8 cm^2 — p=0.52

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: raltegravir (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of California, Los Angeles
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2)	-6.6; 1.8	0.52

Summary

Ritonavir-boosted protease inhibitor (PI) regimens have become a backbone for treatment of people with HIV. However, adverse drug effects, particularly lipodystrophy/lipoatrophy are closely associated with these regimens. Therefore, there is a need for a drug with comparable effectiveness to the ritonavir boosted PIs without the side effects of dyslipidemia, which has been associated with elevated cholesterol and cardiovascular disease Raltegravir is an HIV integrase inhibitor in phase III clinical development. To date there are no approved drugs that target the same stage of the HIV-1 lifecycle. However, data from studies indicate that raltegravir is generally safe and well tolerated and has strong antiretroviral activity when used in combination with licensed antiretroviral medications. This study aims to demonstrate that patients substituting raltegravir for a PI or NNRTI based antiretroviral regimen will be associated with a 10% reduction in body fat over 24 weeks. The study will consist of a total of 10 subject visits over a period of 48 weeks. Approximately 40 female patients will participate in this study (approximately 10 at UCLA).

Eligibility Criteria

Inclusion Criteria

HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry or plasma HIV-1 RNA > 2000 on two occasions,
Female subjects 18 years or older
Documented central fat accumulation (defined by waist circumference of > 94 cm or a waist to hip ratio of > 0.88).
Documented HIV RNA 500 cells/mm3
Hemoglobin 60 ml/min (estimated by Cockcroft-Gault equation)
AST or ALT > 3 x ULN

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00656175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.