Evaluation of Third-line cART Regimen in Cambodia (3DICAM)

• Status: Recruiting
• Trial end date: 2022-04-11
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to evaluate the virological effectiveness of a third-line regimen combining dolutegravir (DTG), ritonavir-boosted darunavir (DRV/r) and optimized NRTI in Cambodian HIV-infected adults, who failed a protease inhibitors (PI)-based second-line regimen despite 3 months of boosted adherence counseling (BAC).

• Phase: Phase 2
• 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)
• Treatments: Darunavir; Dolutegravir; Ritonavir

Criteria

Inclusion Criteria:

• Documented HIV-1 infection

• Failing a NNRTI-based first-line regimen

• Failing a PI-based second-line regimen after 3 months of adherence boosting (HIV RNA > 1000 copies/mL)

• HIV strain intermediate or fully resistant to ATV/r OR sensitive to ATV but both resistant to AZT, ABC and TDF

• For women of childbearing age: acceptance to use effective contraceptive methods

• Informed consent obtained with information sheet given and explained before the inclusion visit and the consent form signed by the participant and the parents or legal guardians for adolescents at the latest the day of the inclusion

Exclusion Criteria:

• History of antiretroviral treatment including darunavir and integrase inhibitor

• Active pregnancy < 12 weeks of amenorrhea and desire of pregnancy during the duration of the study

• Opportunistic infection in acute phase at inclusion including tuberculosis treated since less than one month and/or with no stable clinical condition

• Advanced cirrhosis (Child-Pugh score B or C)

• Creatinine clearance < 50 ml/mn

• Any concomitant medical condition that, according to the clinical site investigator would contraindicate participation in the study

• Concurrent participation in any other clinical study without written agreement of the two study teams