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Structured Treatment Interruption of HAART in HIV-Infected Adults in Abidjan
NCT00158405Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2002
- Countries
- 1
- Sponsor
- ANRS
- Modality
- Small Molecules
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 3, randomised, open-label trial of zidovudine, lamivudine, efavirenz, ritonavir and indinavir in human immunodeficiency virus infection (HIV) (3 arms), sponsored by ANRS. Primary endpoints: Non-inferiority of STI strategies compared with continuous HAART at 24 months, Percentage of patients with CD4 count over 350 per mm3 at 24 months and 2 more. Started Dec 2002; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Continuous HAART
Continuous HAART
Fixed STI strategy
Immutable periods of 2 months on HAART / 4 months off HAART
CD4-guided STI strategy
Unlimited interruption of HAART, and then re-introduction/re-interruption guided by the evolution of the CD4 count (Discontinued)
03
Who it enrols
HIV-infected adults, 18 years or older, HAART-naive, with CD4 count between 150 and 350 per mm3, residing in Abidjan. Excludes pregnant women and those with severe renal, hepatic, or neuropsychiatric diseases.
04
Endpoints
Primary
Non-inferiority of STI strategies compared with continuous HAART
Percentage of patients with CD4 count over 350 per mm3
Incidence of severe morbidity
Incidence of mortality
Secondary
HIV resistance to antiretroviral drugs
Cost-utility
Compliance to treatment
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