Randomised Trial of Structured Treatment Interruption of HAART in HIV-Infected Adults in Abidjan (ANRS 1269 TRIVACAN)

NCT00158405 | Completed Phase 3 DMC

• 1 other identifier: ANRS 1269 TRIVACAN
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 5

Brief Summary

Interrupting HAART during limited periods of time ("structured treatment interruption : STI") could entail benefits (better long term tolerance, lower drug-induced viral resistance, lower cost) but also concomitant risks (lower efficacy, higher drug-induced viral resistance). At present, the benefit/risk ratio of STI is unclear. Several STI trials are in progress in industrialised countries. This trial aim at assessing the benefits and risks of two different STI strategies in West Africa.

Conditions

HIV Infections

Keywords

HIV; Structured treatment interruption; HAART; Sub-saharian africa; Treatment Interruption; Treatment Naive

Outcome Measures

Primary Outcomes (4)

• To assess the non-inferiority at 24 months of two STI strategies of HAART compared with a continuous HAART in terms of :

• Percentage of patients with CD4 count over 350 per mm3

• Incidence of severe morbidity

• Incidence of mortality

Secondary Outcomes (4)

• To compare at 24 months two STI strategies of HAART with a continuous HAART in terms of :

• HIV resistance to antiretroviral drugs

• Cost-utility

• Compliance to treatment

Interventions

Structured Treatment Interruption PROCEDURE

Zidovudine (ZDV) DRUG

Lamivudine (3TC) DRUG

Efavirenz (EFV) DRUG

Ritonavir (NRV) DRUG

Indinavir (IDV) DRUG

Eligibility Criteria

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

You may qualify if:

• Informed consent
• years old or more
• CD4 count between 150 and 350 per mm3 (or CD4 percentage between 12.5 and 20 percent)
• no past history of curative antiretroviral therapy
• residence in Abidjan

You may not qualify if:

• pregnancy
• severe renal failure
• severe hepatic failure
• severe neuropsychiatric disease

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Bristol-Myers Squibb: collaborator

Study Sites (5)

Centre de Prise en Charge et de Formation ACONDA

Abidjan, Côte d’Ivoire

Location

Centre de Suivi des donneurs de sang, Centre National de Transfusion Sanguine

Abidjan, Côte d’Ivoire

Location

Centre Intégré de Recherches Biocliniques d'Abidjan

Abidjan, Côte d’Ivoire

Location

Service des Maladies Infectieuses et Tropicales, CHU de Treichville

Abidjan, Côte d’Ivoire

Location

Unité de Soins Ambulatoires et de Conseil, CHU de Treichville

Abidjan, Côte d’Ivoire

Location

Related Publications (3)

• Moh R, Danel C, Sorho S, Sauvageot D, Anzian A, Minga A, Gomis OB, Konga C, Inwoley A, Gabillard D, Bissagnene E, Salamon R, Anglaret X. Haematological changes in adults receiving a zidovudine-containing HAART regimen in combination with cotrimoxazole in Cote d'Ivoire. Antivir Ther. 2005;10(5):615-24. doi: 10.1177/135965350501000510.

  PMID: 16152755 BACKGROUND

• Danel C, Moh R, Minga A, Anzian A, Ba-Gomis O, Kanga C, Nzunetu G, Gabillard D, Rouet F, Sorho S, Chaix ML, Eholie S, Menan H, Sauvageot D, Bissagnene E, Salamon R, Anglaret X; Trivacan ANRS 1269 trial group. CD4-guided structured antiretroviral treatment interruption strategy in HIV-infected adults in west Africa (Trivacan ANRS 1269 trial): a randomised trial. Lancet. 2006 Jun 17;367(9527):1981-9. doi: 10.1016/S0140-6736(06)68887-9.

  PMID: 16782488 RESULT

• Danel C, Moh R, Chaix ML, Gabillard D, Gnokoro J, Diby CJ, Toni T, Dohoun L, Rouzioux C, Bissagnene E, Salamon R, Anglaret X; Trivacan ANRS 1269 Trial Group. Two-months-off, four-months-on antiretroviral regimen increases the risk of resistance, compared with continuous therapy: a randomized trial involving West African adults. J Infect Dis. 2009 Jan 1;199(1):66-76. doi: 10.1086/595298.

  PMID: 18986246 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Treatment Interruption; Zidovudine; Lamivudine; efavirenz; Ritonavir; Indinavir

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)

Treatment Adherence and Compliance; Attitude to Health; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Pyridines

Study Officials

• Xavier Anglaret, MD

  Unité INSERM 593, Université Victor Segalen Bordeaux 2

  STUDY DIRECTOR

• Christine Danel, MD

  Programme PACCI, Abidjan

  PRINCIPAL INVESTIGATOR

• Roger Salamon, Pr

  Unité INSERM 593, Université Victor Segalen Bordeaux 2

  STUDY CHAIR

• Emmanuel Bissagnene, Pr

  CHU Treichville

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: December 1, 2002
• Study Completion: December 1, 2006
• Last Updated: December 30, 2008

Record last verified: 2008-12

Locations

CÔ (5)