PREventing Progression of Adipose Tissue Redistribution

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of the study is to assess changes in fat distribution over 48 weeks of treatment in patients who currently successfully use zidovudine (AZT) and lamivudine (3TC) as part of their regimen and who will either continue these antiretrovirals or who will switch these antiretrovirals to tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Each of these medications is commonly used for the treatment of HIV-1 infection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Antiviral Therapy Evaluation Center
• Collaborator: Gilead Sciences
• Treatments: Lamivudine, zidovudine drug combination; Tenofovir

Criteria

Inclusion Criteria:

• Providing written informed consent

• HIV-1 infected patients.

• At least 18 years of age.

• Males or non-pregnant, non-lactating females. Women of childbearing age must have a negative urine pregnancy test at screening. All female participants must be encouraged to utilise adequate contraception for the month preceding entry and for the duration of the study.

• Treatment for at least two years with a first-line regimen of zidovudine plus lamivudine (as either a fixed dose combination or dosed separately) plus either an NNRTI or a (boosted) PI. Patients may have previously used multiple drugs from both the NNRTI or the PI classes.

• Plasma HIV-1 RNA levels < 50 copies/mL for at least 6 months at screening. Isolated measurements of plasma HIV-1 RNA levels above 50 but below 200 copies/ml (socalled blips) are allowed.

Exclusion Criteria:

• Prior treatment with an NRTI other than zidovudine or lamivudine.

• Use of a triple NRTI antiretroviral regimen or a regimen including unboosted saquinavir, fusion inhibitors or hydroxyurea

• Prior virological treatment failure, defined as having had to switch antiretroviral therapy because of virologic failure in the opinion of the physician.

• HIV-2 co-infection.

• Renal impairment and/or use of nephrotoxic agents which in the opinion of the investigator are a contraindication for the use of tenofovir disoproxil fumarate.

• Clinically relevant laboratory abnormalities: anemia, thrombocytopenia, leucopenia, elevated liver transaminases, elevated bilirubin, elevated amylase, elevated lipase.

• Use of co-medication, other than antiretroviral drugs, with a known pharmacological interaction with one or more of the study drugs

• Active alcohol or drug use, sufficient in the investigator's opinion to prevent compliance with the dosing schedule and evaluations (methadone and buprenorphine use is allowed, although the dose of methadone might need to be adjusted).

• Anticipated non-compliance with the protocol.

• Presence of a newly (within 30 days prior to the time of enrolment) diagnosed HIV-related opportunistic infection or condition which may interfere with the ability to comply with the study.

• Chronic active viral hepatitis or other chronic liver disease, which in the opinion of the investigator is a contraindication for the use of any of the study drugs.

• Women who have the intention to become pregnant during the study period.

• Patients who have received within 4 weeks prior to entry, or who have an anticipated need for treatment with radiation therapy or cytotoxic chemotherapeutic agents during the protocol study period.

• Patients who have taken any investigational drug 30 days prior to the start of the study

• Patients with malabsorption syndrome or other gastrointestinal dysfunction which may interfere with drug absorption or prevent the patient from taking oral medication.