Clinical trial NCT00196599: Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Antiretroviral Naive
Keywords: HIV infections
Reverse Transcriptase Inhibitors
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: Triangle Pharmaceuticals
name: Gilead Sciences
name: Bristol-Myers Squibb
name: Dupont Applied Biosciences
First posted: 2005-09-20
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Virological success
Secondary outcomes:
measure: Treatment adherence
measure: CD4 cell count
measure: Safety
measure: Progression of HIV infection
measure: Pharmacokinetics criteria
Other outcomes:
Locations:
Study officials:
affiliation: Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France
name: Jean-Michel Molina, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSERM unité 593, Bordeaux, France
name: Genevieve Chene, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.