Efficacy and Tolerance of the Switch From Enfuvirtine to Raltegravir in Antiretroviral Therapy Regimen in HIV Patients With Undetectable Viral Load

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Switching from enfuvirtide to raltegravir in the treatment of HIV-infected patients who sustain viral suppression with a combination therapy including enfuvirtide (or : with an enfuvirtide-based combination therapy)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Efavirenz; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Enfuvirtide; Lopinavir; Raltegravir Potassium; Ritonavir

Criteria

Inclusion Criteria:

• Chronic HIV-1 infection

• Treatment with a well-tolerated combination of antiretroviral drugs unchanged for at least 3 months, including enfuvirtide

• Absence of any uncontrolled opportunistic disease

• No restrictions on CD4 lymphocyte levels

• Plasma HIV-1 RNA below 400 copies per ml for at least 3 months (at least two consecutive tests below 400 copies per ml prior to inclusion in the study, not including that on W -4)

• For women of childbearing age, use of mechanical contraception during any sexual intercourse and negative pregnancy test (plasma ß HCG) at W -4

Exclusion Criteria:

• HIV-2 infection

• Plasma HIV-1 RNA levels above 400 copies/ml on one occasion during the 3 months prior to screening (or the pre-inclusion visit at W -4)

• Poor compliance with antiretroviral therapy current at W -4

• Current treatment with an investigational drug (except cohort ATU)

• Patient previously treated with an integrase inhibitor in the context of a clinical study

• Woman who is pregnant or likely to become so, is breastfeeding or refuses to use contraception

• Multiple drug therapy ongoing or necessary in the foreseeable future for Kaposi's disease or lymphoma

• Treatment with interferon ongoing or necessary in the foreseeable future for chronic hepatitis B or C

• Acute hepatitis whatever the case, or decompensated cirrhosis

• Current treatment with interferon, interleukin or anti-HIV vaccine

• Any condition (including, but not limited to, the consumption of alcohol or drugs) which might, in the investigator's opinion, compromise the safety of treatment and/or patient compliance with the protocol

• Significant biological abnormalities (hemoglobin below 8g per dl, polynuclear neutrophils below 750 per mm3, platelets below 50,000 per mm3, serum creatinine above 3 times the level deemed normal by the laboratory (N), ASAT or ALAT above 5N, serum lipase above 2N) and total bilirubin above 2N (except if the patient is receiving atazanavir or indinavir)

• Concomitant treatments including one or more compounds interacting with UGT1A1

• anti-infective agents: rifampicin/rifampin

• psychotropic/anti-epileptic drugs: phenytoin, phenobarbital.