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

Drug Information available for: Didanosine Emtricitabine Efavirenz

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Molina JM, Journot V, Morand-Joubert L, Yéni P, Rozenbaum W, Rancinan C, Fournier S, Morlat P, Palmer P, Dupont B, Goujard C, Dellamonica P, Collin F, Poizot-Martin I, Chene G; ALIZE (Agence Nationale de Recherches sur le SIDA 099) Study Team. Simplification therapy with once-daily emtricitabine, didanosine, and efavirenz in HIV-1-infected adults with viral suppression receiving a protease inhibitor-based regimen: a randomized trial. J Infect Dis. 2005 Mar 15;191(6):830-9. Epub 2005 Feb 10.


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:


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

ClinicalTrials.gov processed this record on February 25, 2015

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