Overview

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.