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Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults
This study has been completed.
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators:
Triangle Pharmaceuticals
Gilead Sciences
Bristol-Myers Squibb
Dupont Applied Biosciences
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00196599
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:
Primary Outcome Measures:
- Virological success
Secondary Outcome Measures:
- Treatment adherence
- CD4 cell count
- Safety
- Progression of HIV infection
- Pharmacokinetics criteria
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV infection
- Antiretroviral naive
- CD4 cell count over 100/mm3
-
Plasma HIV RNA load over 5,000 copies/mL
- Signed written informed consent
Exclusion Criteria:
- Hepatitis B infection
- Pregnancy
- Alcool abuse
- Acute infection, past neurological or pancreatic disease, biological abnormalities
- Chemotherapy or immunotherapy
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00196599
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196599
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Triangle Pharmaceuticals
Gilead Sciences
Bristol-Myers Squibb
Dupont Applied Biosciences
Investigators
| 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
Publications:
| ClinicalTrials.gov Identifier: | NCT00196599 History of Changes |
| Other Study ID Numbers: |
ANRS 091 MONTANA |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
HIV infections Reverse Transcriptase Inhibitors |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Emtricitabine Efavirenz Didanosine Antiviral Agents Anti-Infective Agents |
Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Antimetabolites |
ClinicalTrials.gov processed this record on August 18, 2017