Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART

June 12, 2026 updated by: ANRS, Emerging Infectious Diseases

Phase II Randomized Trial Comparing Efficacy and Safety of the Maintenance of a HAART Association Protease Inhibitor Containing Versus a Once Daily Antiretroviral Triple Association, in HIV Adult Patients With Undetectable Viral Load.ANRS 099 ALIZE

The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side effects and the same efficacy. The aim of the study was to evaluate if the once daily combination presents the same efficacy than the HAART therapy with less side effects and a better adherence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults, but side effects an the great number of pills induces less adherence to the therapy. Once daily combination with a lower number of pills could be more easy to take, with a greater adherence, less side effects, and the same efficacy. 355 patients are recruited in the study, randomized in two treatment groups: maintenance of the HAART therapy versus changing for a once daily combination of FTC, ddI, efavirenz, during 48 weeks. The primary end-point is the viral success maintained until 48 weeks. Secondary end-point is the safety and adherence.

The trial is prolonged for a total of 48 weeks.

Study Type

Interventional

Enrollment

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • HIV infected adults
  • Antiretroviral treatment since 6 months, with two nucleoside analogues and one or two protease inhibitors
  • CD4 cell count over 100/mm3
  • HIV RNA below 400 copies/ml since 6 months
  • Signed written informed consent

Exclusion Criteria:

  • Previous treatment with non nucleoside analogue, ddI alone
  • Pregnancy
  • Alcool abuse
  • Acute infection, past neurological or pancreatic disease, biological abnormalities
  • Chemotherapy or immunotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Virological success from W0 to W48

Secondary Outcome Measures

Outcome Measure
Quality of life
Safety
CD4 cell count
Treatment adherence
Progression of HIV infection
Viral mutations
Therapeutic strategy failure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Bristol-Myers Squibb
Gilead Sciences
Triangle Pharmaceuticals
Dupont Applied Biosciences

Investigators

  • Principal Investigator: Jean-Michel Molina, MD, PhD, Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France
  • Study Director: Genevieve Chene, MD, PhD, INSERM Unite 593, Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion

September 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimated)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 099 ALIZE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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