Randomised Trial of Structured Treatment Interruption of HAART in HIV-Infected Adults in Abidjan (ANRS 1269 TRIVACAN)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
Côte D'Ivoire
Study Type
Interventional
Intervention
Structured Treatment Interruption
Zidovudine (ZDV)
Lamivudine (3TC)
Efavirenz (EFV)
Ritonavir (NRV)
Indinavir (IDV)
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Structured treatment interruption, HAART, Sub-saharian africa, Treatment Interruption, Treatment Naive
Eligibility Criteria
Inclusion Criteria: Informed consent 18 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 Exclusion Criteria: pregnancy severe renal failure severe hepatic failure severe neuropsychiatric disease
Sites / Locations
- Centre de Prise en Charge et de Formation ACONDA
- Centre de Suivi des donneurs de sang, Centre National de Transfusion Sanguine
- Centre Intégré de Recherches Biocliniques d'Abidjan
- Service des Maladies Infectieuses et Tropicales, CHU de Treichville
- Unité de Soins Ambulatoires et de Conseil, CHU de Treichville
Outcomes
Primary Outcome Measures
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 Outcome Measures
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
Full Information
NCT ID
NCT00158405
First Posted
September 7, 2005
Last Updated
December 29, 2008
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00158405
Brief Title
Randomised Trial of Structured Treatment Interruption of HAART in HIV-Infected Adults in Abidjan (ANRS 1269 TRIVACAN)
Official Title
Multicentric Randomised Controlled Trial Assessing the Efficacy of Two Strategies of Structured Treatment Interruption of Highly Active Antiretroviral Therapy (HAART) Compared With a Continuous HAART in HIV- Infected Adults in Abidjan
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The objective of this study is to assess the non-inferiority of two strategies of structured treatment interruption (STI) of highly active antiretroviral treatment (HAART) compared with a continuous HAART.
It's a multicentric open labeled randomised non-inferiority trial, which takes place in 5 health care centres in Abidjan, the economic capital city of Cote d'Ivoire
The trial was designed in two phases :
Pre-randomisation phase : 840 HAART-naive HIV-infected adults start the following continuous HAART regimen: zidovudine-lamivudine in combination with
preferably efavirenz, for HIV-1 infected men, and HIV-1 infected women with an effective contraception and no history of nevirapine-containing p-MTCT (prevention of mother to child transmission);
ritonavir-indinavir, for HIV-2 infected patients, women not desiring contraception, and women with a past history of p-MTCT with nevirapine.
Trial phase : After at least six months on continuous HAART in the pre-randomisation phase, patients who meet success criteria (CD4 count over 350/mm3, undetectable viral load, absence of current opportunistic infection) are randomised into three arms :
Arm 1: Continuous HAART (1 of 6 patients)
Arm 2: Fixed STI strategy (3 of 6 patients): immutable periods of 2 months on HAART / 4 months off HAART
Arm 3: CD4-guided STI strategy (2 of 6 patients): unlimited interruption of HAART, and then re-introduction/re-interruption guided by the evolution of the CD4 count.
Following the DSMB recommendation, the arm 3 has been discontinued in october 2005. The trial is continuing for patients in the arms 1 and 2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Structured treatment interruption, HAART, Sub-saharian africa, Treatment Interruption, Treatment Naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
840 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Structured Treatment Interruption
Intervention Type
Drug
Intervention Name(s)
Zidovudine (ZDV)
Intervention Type
Drug
Intervention Name(s)
Lamivudine (3TC)
Intervention Type
Drug
Intervention Name(s)
Efavirenz (EFV)
Intervention Type
Drug
Intervention Name(s)
Ritonavir (NRV)
Intervention Type
Drug
Intervention Name(s)
Indinavir (IDV)
Primary Outcome Measure Information:
Title
To assess the non-inferiority at 24 months of two STI strategies of HAART compared with a continuous HAART in terms of :
Title
Percentage of patients with CD4 count over 350 per mm3
Title
Incidence of severe morbidity
Title
Incidence of mortality
Secondary Outcome Measure Information:
Title
To compare at 24 months two STI strategies of HAART with a continuous HAART in terms of :
Title
HIV resistance to antiretroviral drugs
Title
Cost-utility
Title
Compliance to treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent
18 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
Exclusion Criteria:
pregnancy
severe renal failure
severe hepatic failure
severe neuropsychiatric disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Anglaret, MD
Organizational Affiliation
Unité INSERM 593, Université Victor Segalen Bordeaux 2
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christine Danel, MD
Organizational Affiliation
Programme PACCI, Abidjan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roger Salamon, Pr
Organizational Affiliation
Unité INSERM 593, Université Victor Segalen Bordeaux 2
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Emmanuel Bissagnene, Pr
Organizational Affiliation
CHU Treichville
Official's Role
Study Chair
Facility Information:
Facility Name
Centre de Prise en Charge et de Formation ACONDA
City
Abidjan
Country
Côte D'Ivoire
Facility Name
Centre de Suivi des donneurs de sang, Centre National de Transfusion Sanguine
City
Abidjan
Country
Côte D'Ivoire
Facility Name
Centre Intégré de Recherches Biocliniques d'Abidjan
City
Abidjan
Country
Côte D'Ivoire
Facility Name
Service des Maladies Infectieuses et Tropicales, CHU de Treichville
City
Abidjan
Country
Côte D'Ivoire
Facility Name
Unité de Soins Ambulatoires et de Conseil, CHU de Treichville
City
Abidjan
Country
Côte D'Ivoire
12. IPD Sharing Statement
Citations:
PubMed Identifier
16152755
Citation
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.
Results Reference
background
PubMed Identifier
16782488
Citation
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.
Results Reference
result
PubMed Identifier
18986246
Citation
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.
Results Reference
result
Learn more about this trial
Randomised Trial of Structured Treatment Interruption of HAART in HIV-Infected Adults in Abidjan (ANRS 1269 TRIVACAN)
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