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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196599
• Other study ID #: ANRS 091 MONTANA
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: February 1999
• Est. completion date: September 2004

Study information

• Verified date: September 2005
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antiretroviral Naive
• HIV Infections

Intervention

Drug:
• emtricitabine, FTC (drug)

• didanosine, ddI (drug)

• efavirenz (drug)

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis	Bristol-Myers Squibb, Dupont Applied Biosciences, Gilead Sciences, Triangle Pharmaceuticals

References & Publications (2)

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 — View 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 tria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virological success
Secondary	Treatment adherence
Secondary	CD4 cell count
Secondary	Safety
Secondary	Progression of HIV infection
Secondary	Pharmacokinetics criteria