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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00324649 |
This study evaluated changes in body fat distribution in human immunodeficiency virus type 1 (HIV-1) infected participants who either switched from a zidovudine- (AZT) plus lamivudine- (3TC) containing antiretroviral 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 an AZT plus 3TC-containing regimen.
Condition | Intervention | Phase |
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HIV-1 |
Drug: Truvada Drug: AZT/3TC |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pilot Phase IV, Multicenter, Randomized, Open-Label and Controlled Study to Assess the Evolution of Peripheral Body Fat Distribution After Switching From AZT Containing Backbone to Truvada in HIV-1-Infected Patients on HAART (RECOMB Study). |
Enrollment: | 80 |
Study Start Date: | May 2006 |
Study Completion Date: | September 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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TVD: Experimental
Truvada + NNRTI or PI.
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Drug: Truvada
Truvada once daily with continuation of the current NNRTI or PI at randomization.
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AZT/3TC: Active Comparator
AZT/3TC + NNRTI or PI.
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Drug: AZT/3TC
Continuation of the AZT + 3TC containing regimen plus the current NNRTI or PI at randomization.
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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 therapeutic guidelines of the US Department of Health and Human Resources (DHHS) includes two nucleoside reverse transcriptase inhibitors (NRTIs) and a third drug from another class (protease inhibitor [PI] or non-nucleoside reverse transcriptase inhibitor [NNRTI]).
The use of nucleoside analogues, especially stavudine and AZT, is associated with untoward side effects, including lipodystrophy hepatic steatosis/lactic acidosis syndrome, peripheral neuropathy, and anemia. However, Truvada has a low potential for both mitochondrial toxicity and fat distribution disturbances.
As described in the Consensus Document of the Spanish Group for the Study of AIDS (GESIDA), and the AIDS National Plan from the Spanish Ministry of Health "Recommendations on metabolic alterations and body fat distribution", studies should focus on the evaluation of body fat disturbances after antiretroviral drug substitutions, based on the basic assumption of virologic control of the patient and equivalence in potency of the new drug regarding virological control. In addition, studies based on selective substitution of antiretroviral drugs in HIV-1 infected patients under virological control, are recommended in the EMEA in the "Guideline on the clinical development of medicinal products for the treatment of HIV infection".
In this study, stable, virologically controlled, HIV-1 infected participants receiving antiretroviral regimens containing AZT and 3TC were randomized to switch to Truvada or to stay on their AZT- plus 3TC-containing regimen.
Participants in both groups continued the third drug of their antiretroviral regimen (either an NNRTI or PI).
Changes in limb fat in the two groups were assessed using dual-energy x-ray absorptiometry (DEXA).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Gilead Sciences ( Pedro Ferrer ) |
Study ID Numbers: | GS-ES-164-0154 |
Study First Received: | May 9, 2006 |
Results First Received: | March 30, 2009 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00324649 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
HIV-1 |
HIV Infections Acquired Immunodeficiency Syndrome Lamivudine Zidovudine |