Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART
This study has been completed.
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
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
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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:
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 |
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 (Adult, Senior) |
| 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
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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
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Efavirenz Reverse Transcriptase Inhibitors Didanosine Emtricitabine Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Antimetabolites Anti-HIV Agents |
ClinicalTrials.gov processed this record on September 30, 2016