Evaluation of a Maintenance Strategy With Protease Inhibitors With or Without Lamivudine in Virologically Suppressed HIV Patients on Second Line Antiretroviral Treatment in Africa

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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 failure rate at 96 weeks. This study will include 260 participants, former participants of the 2LADY trial. It will be carried out in Yaoundé, Bobo Dioulasso and Dakar.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborator: Janssen Pharmaceuticals
• Treatments: Darunavir; HIV Protease Inhibitors; Lamivudine; Lopinavir; Protease Inhibitors

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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