Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART
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
1 other identifier
interventional
350
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
Started Apr 2001
Typical duration for phase_3 hiv-infections
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedSeptember 20, 2005
September 1, 2005
September 12, 2005
September 12, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Virological success from W0 to W48
Secondary Outcomes (7)
Progression of HIV infection
CD4 cell count
Safety
Treatment adherence
Quality of life
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous treatment with non nucleoside analogue, ddI alone
- Pregnancy
- Alcool abuse
- Acute infection, past neurological or pancreatic disease, biological abnormalities
- Chemotherapy or immunotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- French National Agency for Research on AIDS and Viral Hepatitislead
- Triangle Pharmaceuticalscollaborator
- Gilead Sciencescollaborator
- Bristol-Myers Squibbcollaborator
- Dupont Applied Biosciencescollaborator
Related Publications (1)
Molina JM, Journot V, Morand-Joubert L, Yeni 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. doi: 10.1086/428091. Epub 2005 Feb 10.
PMID: 15717256RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
April 1, 2001
Study Completion
September 1, 2004
Last Updated
September 20, 2005
Record last verified: 2005-09