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

This study has been completed.
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00158470
First received: September 7, 2005
Last updated: July 2, 2007
Last verified: July 2007
  Purpose

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 Intervention Phase
HIV Infection
Drug: efavirenz
Drug: didanosine
Drug: lamivudine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

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

Secondary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT00158470

Locations
Vietnam
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
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
  More Information

No publications provided

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
Health Authority: Vietnam: Ho Chi Minh City Health Service

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014