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Feasibility Study of a Once Daily Antiretroviral Regimen in Vietnam (ANRS 1210 VIETAR)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infection | Drug: efavirenz Drug: didanosine Drug: lamivudine | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Feasibility Study of a Once Daily Antiretroviral Regimen for HIV-Infected Patients With CD4 Below 200/mm3, in Hô Chi Minh City, Vietnam |
- CD4 lymphocyte count after HAART [ Time Frame: 6 months ]
- Evaluation of treatment failures causes [ Time Frame: 12 months ]
- Assessment of patients social and behavioral conditions at different stages during the treatment [ Time Frame: 12 months ]
| Enrollment: | 100 |
| Study Start Date: | September 2003 |
| Study Completion Date: | May 2007 |
Despite a high number of infected subjects (estimated of 250,000 at the end of 2004) and a rapid spread of HIV infection in Vietnam, the use of anti-retroviral therapy remains limited. However, access to care and treatment will be expanded in Vietnam in the next few years with the support of national and international organisations. ANRS 1210 study is the first pilot program using highly active antiretroviral therapy (HAART) to evaluate the efficacy and the tolerance of an antiretroviral therapy delivered to adults in an external system of medical care, in Ho Chi Minh City. This feasibility study has also the objective to evaluate the cause of treatment failures and to assess social and behavioural conditions of patients at different stages during the treatment.
The present study is an open trial with direct individual benefit. The chosen treatment is a once-daily administration of 3TC, ddI and Efavirenz delivered to HIV infected adults with a CD4 count below 200/mm3. The duration of the study is eighteen months with a main evaluation at six months. One hundred patients will be selected in outpatient consultation of Binh Trieu hospital and Tropical Diseases Hospital of Ho Chi Minh City. The main criteria of evaluation will be the immunological response at 6 months, opportunistic infection events and the proportion of patients undergoing a regular monitoring at 6 months. Viral response will be also appreciated but, for technical question, will not be a main criteria of the study.
Patients are also administered a questionnaire by a trained independent interviewer about adherence to treatment, mental well-being, housing and nutrition, drug and sexual behaviour, social support and disclosure in order to study the associations between sociobehavioural dimensions, adherence and viral load at two successive follow-up visits.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Man or woman over 18 years old
- HIV infected
- Written informed consent signed
- CD4 count lower than 200/mm3
- No previous antiretroviral treatment
- Weight over 45 kilos and/or body mass index over 16
- Karnofsky Index over or equal to 70 percent
Exclusion Criteria:
- Pregnant woman or woman without effective contraception
- Opportunistic infection compromising the realisation of the treatment
- Tumoral pathology
- Progressive psychiatric affection
- Previous history of peripheral neuropathy or pancreatitis
- Hemoglobin above 90 g/l
- PMN neutrophil above 1.0G/l
- Platelets above 50G/l
- Liver enzymes over 5 times the normal values
- Lipase and/or amylase over 2 times the normal values
- Prothrombin rate above 50 percent
- Plasmatic creatinine over 200 micromoles/l
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00158470
| Vietnam | |
| Binh Trieu Hospital | |
| Ho Chi Minh City, Vietnam | |
| Tropical Diseases Hospital | |
| Ho Chi Minh City, Vietnam | |
| Study Chair: | Jean Yves Follezou, Pr | CHU Pitié-Salpêtrière, Paris, France |
| Principal Investigator: | Huu Chi Nguyen, Dr | Tropical Diseases Hospital - Ho Chi Minh City - Vietnam |
More Information
| ClinicalTrials.gov Identifier: | NCT00158470 History of Changes |
| Other Study ID Numbers: |
ANRS 1210 VIETAR VIETAR |
| Study First Received: | September 7, 2005 |
| Last Updated: | July 2, 2007 |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
HIV infection injecting drug users HAART once daily regimen Treatment Naive |
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 Lamivudine Efavirenz Didanosine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective 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 |
ClinicalTrials.gov processed this record on August 17, 2017