HIV Infections
Conditions
Keywords
HIV, Structured treatment interruption, HAART, Sub-saharian africa, Treatment Interruption, Treatment Naive
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 : 1. 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. 2. 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.
Interventions
PROCEDUREStructured Treatment Interruption
DRUGZidovudine (ZDV)
DRUGLamivudine (3TC)
DRUGEfavirenz (EFV)
DRUGRitonavir (NRV)
DRUGIndinavir (IDV)
Sponsors
Bristol-Myers Squibb
French National Agency for Research on AIDS and Viral Hepatitis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of mortality | — |
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Côte d’Ivoire
Outcome results
None listed