Status:
COMPLETED
Evaluation of a Maintenance Strategy With Protease Inhibitors With or Without Lamivudine in Virologically Suppressed HIV Patients on Second Line Antiretroviral Treatment in Africa
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Janssen Pharmaceuticals
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Multicenter, randomized, superiority trial to evaluate efficacy of a mono or bi-therapy of protease inhibitors with or without lamivudine over a period of 96 weeks. The primary outcome will be the fai...
Detailed Description
Justification: The interest of treating HIV infection with a single molecule has been clear for a long time. Many clinical trials have been testing the efficacy of such a strategy, mainly using a boos...
Eligibility Criteria
Inclusion
- HIV infection on second line treatment in the 2lady trial for at least 48 weeks
- VL ≤ 200 copies/ml since at least 6 months
- No change in ART in the last 3 months previous to the study
- CD4\> 100 cells/ml
- Signed informed consent
- Adherence \>90
Exclusion
- Previous viral failure (at least 2 consecutive HIV RNA \>1000 copies/ml) while receiving a PI
- Ongoing pregnancy and breast feeding women
- HBsAg positive patients
- opportunistic infection or any severe or progressive disease ongoing or treated in the 3 months before screening
- Subject who in the investigator's opinion is unable to complete the study
- History or symptoms of HIV encephalopathy
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT01905059
Start Date
February 1 2014
End Date
February 1 2017
Last Update
July 21 2017
Active Locations (5)
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1
Day Care Center CHU Sanou Sauro
Bobo-Dioulasso, Burkina Faso
2
Central Hospital
Yaoundé, Cameroon
3
Military Hospital
Yaoundé, Cameroon
4
CRCF Hopital de Fann
Dakar, Senegal