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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00196599

Enrollment

Registered

2005-09-20

Start date

1999-02-01

Completion date

2004-09-01

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiretroviral Naive, HIV Infections

Keywords

HIV infections, Reverse Transcriptase Inhibitors

Brief summary

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.

Detailed 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.

Interventions

DRUGemtricitabine, FTC (drug)

DRUGdidanosine, ddI (drug)

DRUGefavirenz (drug)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Virological success	—

Secondary

Measure	Time frame
Treatment adherence	—
CD4 cell count	—
Safety	—
Progression of HIV infection	—
Pharmacokinetics criteria	—

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJean-Michel Molina, MD, PhD

Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France

STUDY_DIRECTORGenevieve Chene, MD, PhD

INSERM unité 593, Bordeaux, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026