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

NCT00196599 | Completed Phase 2

• 1 other identifier: ANRS 091 MONTANA
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV Infections; Antiretroviral Naive

Keywords

HIV infections; Reverse Transcriptase Inhibitors

Outcome Measures

Primary Outcomes (1)

• Virological success

Secondary Outcomes (5)

• Treatment adherence

• CD4 cell count

• Safety

• Progression of HIV infection

• Pharmacokinetics criteria

Interventions

emtricitabine, FTC (drug) DRUG

didanosine, ddI (drug) DRUG

efavirenz (drug) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infection
• Antiretroviral naive
• CD4 cell count over 100/mm3
• Plasma HIV RNA load over 5,000 copies/mL
• Signed written informed consent

You may not qualify if:

• Hepatitis B infection
• Pregnancy
• Alcool abuse
• Acute infection, past neurological or pancreatic disease, biological abnormalities
• Chemotherapy or immunotherapy

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Triangle Pharmaceuticals: collaborator
• Gilead Sciences: collaborator
• Bristol-Myers Squibb: collaborator
• Dupont Applied Biosciences: collaborator

Related Publications (2)

• Molina JM, Ferchal F, Rancinan C, Raffi F, Rozenbaum W, Sereni D, Morlat P, Journot V, Decazes JM, Chene 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. doi: 10.1086/315711. Epub 2000 Jul 13.

  PMID: 10915095 RESULT

• 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. doi: 10.1111/j.1468-1293.2004.00194.x.

  PMID: 15012649 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Emtricitabine; Racivir; Pharmaceutical Preparations; Didanosine; efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dideoxynucleosides; Ribonucleosides

Study Officials

• Jean-Michel Molina, MD, PhD

  Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France

  PRINCIPAL INVESTIGATOR

• Genevieve Chene, MD, PhD

  INSERM unité 593, Bordeaux, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: February 1, 1999
• Study Completion: September 1, 2004
• Last Updated: September 20, 2005

Record last verified: 2005-09