Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00196599

First Posted: September 20, 2005

Last Update Posted: December 9, 2005

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Triangle Pharmaceuticals

Gilead Sciences

Bristol-Myers Squibb

Dupont Applied Biosciences

Information provided by:

French National Agency for Research on AIDS and Viral Hepatitis

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Efavirenz

U.S. FDA Resources

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

Detailed Description:

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

Molina JM, Ferchal F, Rancinan C, Raffi F, Rozenbaum W, Sereni D, Morlat P, Journot V, Decazes JM, Chêne G. Once-daily combination therapy with emtricitabine, didanosine, and efavirenz in human immunodeficiency virus-infected patients. J Infect Dis. 2000 Aug;182(2):599-602. Epub 2000 Jul 13.

Molina JM, Peytavin G, Perusat S, Lascoux-Combes C, Sereni D, Rozenbaum W, Chene G. Pharmacokinetics of emtricitabine, didanosine and efavirenz administered once-daily for the treatment of HIV-infected adults (pharmacokinetic substudy of the ANRS 091 trial). HIV Med. 2004 Mar;5(2):99-104.


ClinicalTrials.gov Identifier:	NCT00196599 History of Changes
Other Study ID Numbers:	ANRS 091 MONTANA
First Submitted:	September 12, 2005
First Posted:	September 20, 2005
Last Update Posted:	December 9, 2005
Last Verified:	September 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

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