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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 |
|---|---|
| Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT00196599 |
Purpose
In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Such therapy induces side effects and the number of pills may reduce therapy adherence.
The aim of this study is to evaluate the efficacy and the safety of a once daily FTC, ddI, efavirenz combination, in HIV patients with CD4 cell count over 100/mm3, antiretroviral naive.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Antiretroviral Naive |
Drug: emtricitabine, FTC (drug) Drug: didanosine, ddI (drug) Drug: efavirenz (drug) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Pilot Study on Efficacy and Safety of a Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults. ANRS 091 MONTANA |
| Estimated Enrollment: | 39 |
| Study Start Date: | February 1999 |
| Estimated Study Completion Date: | September 2004 |
In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Side effects of this products and the number of pills may induce a lower adherence, and thus a lower efficacy. 40 patients with a CD4 count over 100/mm3, a HIV RNA over 5,000 copies/ml and antiretroviral naive, take the once daily combination of FTC, ddI, efavirenz during 24 weeks. The primary end-point is the viral success maintained from 12 weeks until 24 weeks. Secondary end-point is the adherence to the association and safety. The trial is prolonged during a total of 72 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Plasma HIV RNA load over 5,000 copies/mL
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | ANRS 091 MONTANA |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
| ClinicalTrials.gov Identifier: | NCT00196599 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
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HIV infections Reverse Transcriptase Inhibitors |
|
Anti-Infective Agents Efavirenz Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors |
Virus Diseases Didanosine Emtricitabine Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
|
Anti-Infective Agents Efavirenz RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents Emtricitabine HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
