Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART
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ClinicalTrials.gov Identifier: NCT00196612 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: September 20, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: emtricitabine, FTC (drug) Drug: didanosine, ddI (drug) Drug: efavirenz (drug) | Phase 3 |
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 (Clinical Trial) |
Enrollment : | 350 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | April 2001 |
Study Completion Date : | September 2004 |

- Virological success from W0 to W48
- Progression of HIV infection
- CD4 cell count
- Safety
- Treatment adherence
- Quality of life
- Viral mutations
- Therapeutic strategy failure

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196612
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 |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00196612 History of Changes |
Other Study ID Numbers: |
ANRS 099 ALIZE |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | September 20, 2005 |
Last Verified: | September 2005 |
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 Emtricitabine Efavirenz Didanosine Antiviral Agents Anti-Infective Agents |
Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV 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 |