HIV-infected individuals with lipodystrophy
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Provide written informed consent and capable of reading and comprehending the informed consent - HIV-1 infected subjects receiving current antiretroviral therapy defined as 2 NRTIs and a bosted PI for at least 12 weeks prior to screening. Prior treatment with PI or non-PI containing regimen(s) is allowed but subjects may not have experienced confirmed virological failure to more than one prior PI-containing regimen. - Subjects who have controlled virological response defined as HIV RNA level 0.90 and WC > 88.2 cm for men and WHR > 0.90 and WC > 75.3 cm for women. - Men and women, ages 18 years of age or older - Both females of child-bearing potential and males must utilize effective barrier contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study. 2) WOCBP using a prohibited contraceptive method. 3) Women who are pregnant or breastfeeding. 4) Women with a positive pregnancy test on enrollment or prior to study drug administration. 5) Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment. 6) Active alcohol or substance use sufficient, in the investigator’s opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis. 7) Screening laboratory values measured as follows: a) Grade IV glucose, b) Grade IV electrolytes, c) Grade IV transaminases, d) Grade IV hematology. 8) Hypersensitivity to any component of the formulation of study drug. 9) Prior history of taking ATV. 10) Prohibited concomitant therapies (see Protocol Section 6.4.1), including the use of NNRTIs. 11) Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements. 12) Prisoners or subjects who are compulsorily detained
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare changes in trunk-to-limb fat ratio at week 48 by dual energy x-ray absorptiometry (DEXA) in HIV-1 infected subjects with lipohypertrophy, after switching to an ATV/RTV containing regimen versus remaining on current boosted PI-containing HAART regimen.;Secondary Objective: In subjects who switch to an ATV/RTV containing regimen vs current boosted PI-containing HAART regimen: • To assess changes from baseline in : - physical signs of lipohypertrophy - physical signs of lipoatrophy - total body fat - truncal and appendicular fat - fasting lipid parameters - fasting glucose, insulin, C-peptide, and the insulin resistance index • To evaluate changes from baseline in physical measurements • To assess the safety and efficacy of switching to an ATV/RTV containing regimen vs remaining on current PI-containing HAART regimen • To assess the time to confirmed virological rebound for subjects with HIV RNA levels < 400 c/mL at baseline in terms of a hazard ratio • To assess changes from baseline in CD4 cell count • To assess changes in exploratory biochemical markers Objective of the amendment: to collect blood samples for future exploratory research to identify genetic markers that potentially predict drug responses and disease pathophysiology.;Primary end point(s): The primary analysis will compare treatment groups using the difference in the mean change from baseline in trunk-to-limb fat ratio as measured by DEXA at Week 48 with a 95% confidence interval (CI). | — |
Countries
Germany, Italy, Spain, United Kingdom
Outcome results
None listed