A Multicentre Trial of Second-line Antiretroviral Treatment Strategies in African Adults Using Atazanavir or Lopinavir/Ritonavir
Information source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV
Intervention: Lopinavir (Drug); Atazanavir (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) Official(s) and/or principal investigator(s): Eric Delaporte, Principal Investigator, Affiliation: Institut de Recherche pour le Developpement, France Issakwisa Mwakyula, Principal Investigator, Affiliation: NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital, Tanzania Mzileni O Mogiyana, Principal Investigator, Affiliation: University of Limpopo Alexandra Calmy, Principal Investigator, Affiliation: University of Geneva, Switzerland
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 patients often change treatment after a long period of viral
replication while on first line regimen.
This multicentre international, randomized, non-blinded phase III trial aim to demonstrate
the non-inferiority of a generic lamivudine-tenofovir-atazanavir/ritonavir regimen (daily
intake) as compared to a standard emtricitabine-tenofovir-lopinavir/ritonavir (twice daily
intake)regimen for second line HIV-1 treatment. by stratifying on the viral load level
(between 1000 and 5000 copies/mL versus > 5000 copies/mL) at inclusion, this trial will also
allow to evaluate the optimum moment for instituting the second-line treatment.
Clinical Details
Official title: A Multicenter Phase III Trial of Second-line Antiretroviral Treatment Strategies in African Adults (Tanzania Ans South Africa) Using Atazanavir or Lopinavir/Ritonavir
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Virological response
Secondary outcome: Virological responseViral resistance Clinical course of HIV infection Tolerance assessment Adherence assessment Hepatitis B evaluation Immunologic response
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Tshepang clinic, Limpopo University, Pretoria, South Africa
NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital, Mbeya, Tanzania
Additional Information
Starting date: March 2012
Last updated: November 7, 2012
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