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Feasibility Study of a Once Daily Antiretroviral Regimen in Vietnam (ANRS 1210 VIETAR)

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ClinicalTrials.gov Identifier: NCT00158470
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 3, 2007
Information provided by:

Study Description
Brief Summary:
Access to care and treatment using antiretroviral drugs will be expanded in Vietnam in the next few years. The ANRS 1210 study is a pilot program to evaluate the feasibility of a simplified antiretroviral treatment using three antiretroviral drugs once a day. The objectives will be to assess the efficacy and the tolerance of this treatment and to better understand the difficulties linked to social and behavioural conditions of patients at different stages during the treatment.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: efavirenz Drug: didanosine Drug: lamivudine Phase 3

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : September 2003
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. CD4 lymphocyte count after HAART [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Evaluation of treatment failures causes [ Time Frame: 12 months ]
  2. Assessment of patients social and behavioral conditions at different stages during the treatment [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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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:

  • 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 Locations

Information from the National Library of Medicine

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): NCT00158470

Binh Trieu Hospital
Ho Chi Minh City, Vietnam
Tropical Diseases Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
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
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 3, 2007
Last Verified: July 2007

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV infection
injecting drug users
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
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