Status:
WITHDRAWN
A Multicentre Trial of Second-line Antiretroviral Treatment Strategies in African Adults Using Atazanavir or Lopinavir/Ritonavir
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Ludwig-Maximilians - University of Munich
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In the well recognized context of HIV infection chronicity, it is now crucial to identify and evaluate effective, well tolerated and affordable second line regimen in resources limited countries where...
Eligibility Criteria
Inclusion
- age 18 and above
- out patient
- documented HIV-1 infection
- first line treatment failure:
- after first-line antiretroviral treatment with a combination including a non-nucleoside reverse transcriptase inhibitor and two nucleoside reverse transcriptase inhibitors
- two measurements of plasma HIV RNA levels \> 1000 copies/mL after at least 6 months of uninterrupted treatment or without any major modification
- satisfactory compliance (\>80%) to 1st line antiretroviral treatment
- signed informed consent
- agreement for contraception for women of childbearing age
Exclusion
- HIV-2 infection or HIV-1/HIV-2 coinfection
- uncontrolled, ongoing opportunistic infection or of any severe or progressive disease including active TB
- first line antiretroviral treatment with a protease inhibitor or tenofovir
- ongoing treatment with rifampicin
- severe hepatic insufficiency (PT \< 50%)
- ALT \< 3 times the upper limit of normal
- creatinine clearance calculated by Cockcroft's formula \< 50 mL/min
- Hb \<=8 g/dL; platelets \< 50,000 cells/mm3; neutrophils \< 500 cells/mm3
- pregnancy and lactation
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01255371
Start Date
March 1 2012
End Date
December 1 2014
Last Update
November 8 2012
Active Locations (2)
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1
Tshepang clinic, Limpopo University
Pretoria, South Africa
2
NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital
Mbeya, Tanzania