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Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART

This study has been completed.
Sponsor:
Collaborators:
Triangle Pharmaceuticals
Gilead Sciences
Bristol-Myers Squibb
Dupont Applied Biosciences
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00196612
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
HIV Infections
 Drug: emtricitabine, FTC (drug)
Drug: didanosine, ddI (drug)
Drug: efavirenz (drug)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • Virological success from W0 to W48

Secondary Outcome Measures:
  • Progression of HIV infection
  • CD4 cell count
  • Safety
  • Treatment adherence
  • Quality of life
  • Viral mutations
  • Therapeutic strategy failure

Estimated Enrollment: 350
Study Start Date: April 2001
Estimated Study Completion Date: September 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196612

Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Triangle Pharmaceuticals
Gilead Sciences
Bristol-Myers Squibb
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 unité 593, Bordeaux, France
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00196612     History of Changes
Other Study ID Numbers: ANRS 099 ALIZE
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United States: Food and Drug Administration

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV Infections
Reverse Transcriptase Inhibitors
Treatment simplification

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Didanosine
Reverse Transcriptase Inhibitors
 Efavirenz
Emtricitabine
Protease Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on June 17, 2013