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

This study has been completed.
Sponsor:
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

September 12, 2005
September 12, 2005
February 1999
Not Provided
Virological success
Same as current
No Changes Posted
  • Treatment adherence
  • CD4 cell count
  • Safety
  • Progression of HIV infection
  • Pharmacokinetics criteria
Same as current
Not Provided
Not Provided
 
Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults
Pilot Study on Efficacy and Safety of a Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults. ANRS 091 MONTANA

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Antiretroviral Naive
  • Drug: emtricitabine, FTC (drug)
  • Drug: didanosine, ddI (drug)
  • Drug: efavirenz (drug)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
September 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00196599
ANRS 091 MONTANA
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
  • Triangle Pharmaceuticals
  • Gilead Sciences
  • Bristol-Myers Squibb
  • Dupont Applied Biosciences
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
French National Agency for Research on AIDS and Viral Hepatitis
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP