Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada

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

Summary

This study evaluated changes in body fat distribution in human immunodeficiency virus type 1 (HIV-1) infected participants who either switched from a zidovudine- plus lamivudine- containing highly active antiretroviral therapy (HAART) regimen to a regimen containing Truvada® (a fixed-dose combination tablet of emtricitabine [FTC, 200 mg] and tenofovir disoproxil fumarate [TDF, 300 mg]) or who remained on a zidovudine- plus lamivudine-containing regimen. Subjects continued their protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI).

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

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine; Zidovudine

Criteria

Inclusion Criteria:

• HIV-1 infection documented by confirmed positive HIV-1 antibody test and/or positive polymerase chain reaction for HIV-1 ribonucleic acid (RNA).

• Adult patients (over 18 years of age).

• Current HAART regimen containing zidovudine + lamivudine at usual doses for at least 6 months.

• Viral load < 50 copies/mL on the last two consecutive determinations, under zidovudine + lamivudine containing HAART regimen.

• For women of childbearing potential, negative urine pregnancy test at screening visit.

• Agreement to take part in the study and sign the informed consent.

• Patients on lipid lowering treatment were allowed to participate in the study only if the lipid-lowering treatment (either statins or fibrates) was stable for at least 8 weeks prior to screening and it was not expected to change during the first 3 months of the study.

Exclusion Criteria:

• Patients on current FTC or TDF therapy.

• Patients with previous history of virological failure on an FTC or TDF-containing regimen.

• Patients receiving a non-registered antiretroviral drug.

• Patients receiving a triple-nucleoside antiretroviral combination.

• Hypersensitivity to one of the components of the dosage forms of TDF or FTC, or previous history of intolerance to one of those drugs.

• Known history of drug abuse or chronic alcohol consumption

• Women who were pregnant or breast feeding, or female of childbearing potential who did not use an adequate method of contraception according to the investigator's judgment.

• Active opportunistic infection or documented infection within the previous 4 weeks.

• Documented active malignant disease (excluding Kaposi sarcoma limited to the skin).

• Renal disease with creatinine clearance < 50 mL/min.

• Concomitant use of nephrotoxic or immuno-suppressive drugs which could not be stopped without affecting the safety of the patient.

• Receiving on-going therapy with systemic corticosteroids, Interleukin-2 or chemotherapy.

• Patients who were not to be included in the study according to the investigator's criterion.