Evaluation of Low-dose Darunavir in a Switch Study

• Status: Completed
• Trial end date: 2018-05-16
• Target enrollment: 0
• Participant gender: All

Summary

This is a switch study to assess the non-inferiority (in terms of efficacy and safety) of darunavir (boosted with ritonavir, DRV/r 400mg/100mg daily) when compared with lopinavir (boosted with ritonavir, LPV/r total dose 800mg/200mg daily), in combination with a nucleoside backbone, administered as a second line therapy in HIV positive individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Willem Daniel Francois Venter
• Collaborator: Medical Research Council, South Africa
• Treatments: Darunavir; Lopinavir; Reverse Transcriptase Inhibitors; Ritonavir

Criteria

Inclusion Criteria:

• Participant is aged ≥18 years

• Participant weight >40kg

• Participant is on a LPV/r-containing regimen for at least 6 months with no history of other protease inhibitors

• Participant has a plasma HIV-1 RNA level <50 copies/mL in the last 60 days

• Participant is informed and has the ability to comprehend the full nature and purpose of the study, and give voluntary written informed consent before inclusion in the study

Exclusion Criteria:

• Participants who are taking any antiretrovirals other than nucleoside/nucleotide reverse transcriptase inhibitors and LPV/r

• Any prior history of genotype-documented protease inhibitor resistance

• Participants who are taking rifampicin or any other therapy with major cytochrome P450 interactions, within the last month

• Participants who are allergic to sulphonamides

• Participants who have a current history of drug or alcohol abuse that, in the opinion of the investigator, may be an impediment to participant adherence to the protocol

• Female participants who are currently pregnant or breastfeeding

• Female participants desiring pregnancy during the next year

• Participants who have a strong likelihood of relocating far enough to make access to the study site difficult

• Any condition(s) or laboratory report that, in the opinion of the investigator, might put the participant at risk, or interfere with the study objectives or the participant's adherence to study requirements