HIV Infections, HIV Lipodystrophy Syndrome
Conditions
Keywords
HIV infections, HIV Lipodystrophy Syndrome
Brief summary
The aim of this trial is to evaluate the impact on fat distribution of switching to NRTI-sparing regimens in lipoatrophic antiretroviral experienced patients with complete viral suppression. Maintenance of virological suppression and immunological factors are also assessed.
Detailed description
Limitations on achieving complete HIV eradication render it necessary to maintain highly active antiretroviral treatment over long periods, which may lead to the development of antiretroviral-associated toxicities. The current standard-of-care HAART regimens include a backbone of 2 nucleoside reverse transcriptase inhibitors (NRTIs). Many studies have demonstrated that NRTIs particularly thymidine analogue nucleosides are important contributors to the development of lipoatrophy. This antiretroviral family inhibits also the mitochondrial gamma-DNA polymerase, which leads to mitochondrial dysfunction and side effects such as peripheral neuropathy, pancreatitis and liver dysfunction.
Interventions
Sponsors
French National Agency for Research on AIDS and Viral Hepatitis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and non-pregnant females * Confirmed laboratory diagnosis of HIV infection * Patients receiving a 2 or 3 NRTI-containing antiretroviral treatment for at least 3 months * Viral load below 400 copies/ml * Patients with a clinical peripheral lipoatrophy isolated or associated with a lipohypertrophy self reported by the patient and confirmed by physical examination
Exclusion criteria
* Current antiretroviral therapy with 3 classes of antiretroviral therapy * Previous virologic failure with a non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) * Intolerance to nevirapine and efavirenz * Acute opportunistic infection * Diabetes * Transaminase levels over 5 times above the upper normal limit * Hepatitis B virus (HBV) co-infection if the patient is receiving lamivudine therapy * Ongoing immunotherapy including interleukin-2 (IL-2) and interferon * Pregnancy or planned pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evolution from inclusion to week 48 of the peripheral fat tissue measured on computed tomography (CT) scan by a volumetric fat centralized evaluation of the thighs | — |
Secondary
| Measure | Time frame |
|---|---|
| Evolution of the viral load (VL) from inclusion to week 48 and proportion of patients with a VL over 400 copies/ml at week 48 | — |
| Change in CD4 cell count between day 0 (D0) and week 48 | — |
| Change in lipid profile and glucidic metabolism between D0 and week 48 | — |
| Evolution of SAT/TAT and VAT/TAT between D0 and week 48 | — |
Countries
France
Outcome results
None listed