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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Completed

Phase 2

Conditions

Antiretroviral Naive

HIV Infections

Treatments

Drug: didanosine, ddI (drug)

Drug: efavirenz (drug)

Drug: emtricitabine, FTC (drug)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00196599

ANRS 091 MONTANA

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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