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

July 2, 2007 updated by: French National Agency for Research on AIDS and Viral Hepatitis

Feasibility Study of a Once Daily Antiretroviral Regimen for HIV-Infected Patients With CD4 Below 200/mm3, in Hô Chi Minh City, Vietnam

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Binh Trieu Hospital
      • Ho Chi Minh City, Vietnam
        • Tropical Diseases Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CD4 lymphocyte count after HAART
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of treatment failures causes
Time Frame: 12 months
12 months
Assessment of patients social and behavioral conditions at different stages during the treatment
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

July 3, 2007

Last Update Submitted That Met QC Criteria

July 2, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 1210 VIETAR
  • VIETAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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