Status:
COMPLETED
Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of the trial is to assess the ability of an early and intermittent antiretroviral therapy in maintaining an immunological stability in antiretroviral naive HIV infected adults, t...
Eligibility Criteria
Inclusion
- adult confirmed HIV-1 infection
- no previous treatment with antiretroviral drugs or interleukin-2
- CD4 count ≥ 500/mm3
- no active opportunistic infection
- written informed consent
Exclusion
- non barrier contraception in women of child bearing potential, pregnant or breastfeeding woman, pregnancy project within the next 2 years
- HIV-2 infection (with or without HIV-1), recent HIV primary infection, resistance to trial drugs at study entry, Ag HBs+, HCV requiring specific therapy
- previous history of cerebrovascular accident or coronary heart disease, splenectomy
- previous CD4 count \< 400/mm3
- CD4 percentage \< 15%
- hemoglobin \< 8 g/dl, neutrophils \< 750/mm3, platelets \< 100.000/mm3, creatinine clearance \< 50 ml/mn, AST or ALT or total bilirubin \> 3 ULN
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00820118
Start Date
May 1 2009
End Date
May 1 2012
Last Update
May 23 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Services maladies infectieuses et tropicales CHU
Dijon, France