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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00323492 |
This study looks at lipid changes in HIV infected patients when they are switched from existing HIV treatment to a treatment containing Truvada.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Truvada Drug: Current HAART regimen |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Pilot Open-Label Randomized Multicentre Trial to Evaluate the Impact of the Substitution of the NRTIs With TRUVADA in a HAART Combination Over the Lipids Profile in HIV+ Infected Patients |
Estimated Enrollment: | 120 |
Study Start Date: | April 2005 |
Study Completion Date: | August 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1A: Experimental
Phase 1, Day-14 to Week12:the TVD group (substitution of their current NRTIs by TVD [TDF+FTC] with continuation of their current NNRTI or PI at the same dose)
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Drug: Truvada
TVD [TDF+FTC] with continuation of their current NNRTI or PI at the same dose
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1B: Active Comparator
Phase 1, Day-14 to Week12: a control group (continuation of previous HAART regimen)
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Drug: Current HAART regimen |
2: Experimental
Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the TVD group (Arm A) continue with TVD + an NNRTI or PI. Patients who did not switch in Phase 1 to TVD (Arm B) will be proposed to switch in this phase of the study.
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Drug: Truvada
TVD [TDF+FTC] with continuation of their current NNRTI or PI at the same dose
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This is a Phase IV, multicenter (in France) and open label study. The study is conducted in two phases, a comparative randomized phase, which serves the primary objective of the study, and a follow up phase.
Phase 1, Day-14 to Week12: patients will be, on a 1:1 basis, randomized to two arms: A. the TVD group (substitution of their current NRTIs by TVD [TDF+FTC] with continuation of their current NNRTI or PI at the same dose) or B. a control group (continuation of previous HAART regimen). This phase of the study serves the Primary objective of the study.
Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the TVD group (Arm A) continue with TVD + an NNRTI or PI. Patients who did not switch in Phase 1 to TVD (Arm B) will be proposed to switch in this phase of the study.
Patients will be assessed for efficacy and safety during both phases of the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Responsible Party: | Gilead Sciences ( Camille Aubron-Olivier ) |
Study ID Numbers: | GS-FR-164-0109 |
Study First Received: | May 5, 2006 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00323492 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
HIV 1 Infection |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |