Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults
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.
Drug: emtricitabine, FTC (drug)
Drug: didanosine, ddI (drug)
Drug: efavirenz (drug)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Virological success
- Treatment adherence
- CD4 cell count
- Progression of HIV infection
- Pharmacokinetics criteria
|Study Start Date:||February 1999|
|Estimated Study Completion Date:||September 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196599
|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|