Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-Infected Patients in Virological Failure.

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Amprenavir (drug); Drug: ABT-378/r (drug); Drug: Ritonavir (drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT00196625

ANRS 104 PUZZLE1

Details and patient eligibility

About

HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors, over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed.

Full description

HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors (NRTI), over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed. 100 patients with CD4 cell count below 300/mm3 and plasma HIV RNA over 30,000 copies/ml are to be included in four groups: amprenavir, lopinavir, NRTI, with ritonavir 200 mg.d or not (patients previously treated by additional ritonavir 200 or 400 mg/d).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented HIV infection
• CD4 cell count below 300/mm3
• Plasma HIV RNA over 30,000 copies/ml
• Previously treated with 2 protease inhibitors and 1 non nucleoside analogue (except amprenavir, lopinavir)
• Written informed consent

Exclusion criteria

• Biological abnormalities
• Pregnancy
• Alcool abuse
• History of pancreatitis, hepatic failure
• Acute HIV related infection
• Chemotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)