Trial | NCT00196599  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    39
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.
Study Started
Feb 28
1999
Study Completion
Sep 30
2004
Last Update
Sep 20
2005
Estimate

Drug emtricitabine, FTC (drug)

Drug didanosine, ddI (drug)

Drug efavirenz (drug)

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
No Results Posted