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

NCT00196599

CompletedPhase 2

Sponsor: ANRS, Emerging Infectious Diseases

Conditions: HIV Infections, Antiretroviral Naive

Interventions: emtricitabine, FTC (drug), didanosine, ddI (drug), efavirenz (drug)

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Paris, France