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

NCT00158470 | Completed Phase 3

• 2 other identifiers: ANRS 1210 VIETARVIETAR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infection

Keywords

HIV infection; injecting drug users; HAART; once daily regimen; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• CD4 lymphocyte count after HAART

  6 months

Secondary Outcomes (2)

• Evaluation of treatment failures causes

  12 months

• Assessment of patients social and behavioral conditions at different stages during the treatment

  12 months

Interventions

efavirenz DRUG

didanosine DRUG

lamivudine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (2)

Binh Trieu Hospital

Ho Chi Minh City, Vietnam

Location

Tropical Diseases Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

HIV Infections

Interventions

efavirenz; Didanosine; Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jean Yves Follezou, Pr

  CHU Pitié-Salpêtrière, Paris, France

  STUDY CHAIR

• Huu Chi Nguyen, Dr

  Tropical Diseases Hospital - Ho Chi Minh City - Vietnam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: September 1, 2003
• Study Completion: May 1, 2007
• Last Updated: July 3, 2007

Record last verified: 2007-07

Locations

VN (2)