Status:
COMPLETED
Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada
Lead Sponsor:
Gilead Sciences
Conditions:
HIV-1
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 act...
Detailed Description
Standard care for the treatment of HIV infection involves the use of a combination of three antiretroviral drugs. The initial recommended regimen in antiretroviral-naive patients according to therapeu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00324649
Start Date
May 1 2006
End Date
September 1 2008
Last Update
August 17 2015
Active Locations (1)
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1
Gilead Sciences, S.L.
Madrid, Spain, E-28036