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Sponsors and Collaborators: |
French National Agency for Research on AIDS and Viral Hepatitis Triangle Pharmaceuticals Gilead Sciences Bristol-Myers Squibb Dupont Pharmaceuticals |
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Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00196612 |
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side effects and the same efficacy. The aim of the study was to evaluate if the once daily combination presents the same efficacy than the HAART therapy with less side effects and a better adherence.
Condition | Intervention | Phase |
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HIV Infections |
Drug: emtricitabine, FTC (drug) Drug: didanosine, ddI (drug) Drug: efavirenz (drug) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Randomized Trial Comparing Efficacy and Safety of the Maintenance of a HAART Association Protease Inhibitor Containing Versus a Once Daily Antiretroviral Triple Association, in HIV Adult Patients With Undetectable Viral Load.ANRS 099 ALIZE |
Estimated Enrollment: | 350 |
Study Start Date: | April 2001 |
Estimated Study Completion Date: | September 2004 |
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults, but side effects an the great number of pills induces less adherence to the therapy. Once daily combination with a lower number of pills could be more easy to take, with a greater adherence, less side effects, and the same efficacy. 355 patients are recruited in the study, randomized in two treatment groups: maintenance of the HAART therapy versus changing for a once daily combination of FTC, ddI, efavirenz, during 48 weeks. The primary end-point is the viral success maintained until 48 weeks. Secondary end-point is the safety and adherence.
The trial is prolonged for a total of 48 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Jean-Michel Molina, MD, PhD | Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France |
Study Director: | Genevieve Chene, MD, PhD | INSERM unité 593, Bordeaux, France |
Study ID Numbers: | ANRS 099 ALIZE |
Study First Received: | September 12, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00196612 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; United States: Food and Drug Administration |
HIV Infections Reverse Transcriptase Inhibitors Treatment simplification |
Virus Diseases Efavirenz Sexually Transmitted Diseases, Viral Didanosine Emtricitabine |
HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Therapeutic Uses |
Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |