Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada
Condition: HIV-1
Intervention: Truvada; Zidovudine/lamivudine
Intervention description: Truvada once daily with continuation of the current NNRTI or PI at randomization.; Continuation of the zidovudine + lamivudine containing regimen plus the current NNRTI or PI at randomization.
Intervention MeSH terms: Lamivudine; Zidovudine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1

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).
    

Eligibility 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.