A Trial to compare dolutegravir with pharmaco-enhanced darunavir versus dolutegravir with predetermined nucleosides versus recommended standard of care antiretroviral regimens in patients with HIV-1 infection who have failed recommended first line therapy.
Phase 3
- Conditions
- Health Condition 1: B20- Human immunodeficiency virus [HIV]disease
- Registration Number
- CTRI/2019/10/021504
- Lead Sponsor
- niversity of New South Wales
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. HIV-1 positive by licensed diagnostic test
2. Aged >=18 years of age
3. Failed first-line non-nucleoside reverse transcriptase inhibitor (NNRTI) + 2NRTI combination therapy according to virological criteria, defined as at least two consecutive (>=7 days apart) pVL results >500 copies/mL after a minimum period of exposure to continuous NNRTI + 2NRTI firstline therapy of 24 weeks (only the second pVL result needs to be within 45 days of randomisation)
4. For women of child-bearing potential, willingness to use appropriate contraception
5. Able to provide written informed consent
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In HIV-infected patients who have virologically failed first-line ART a regimen of second-line ART incorporating ritonavir boosted darunavir (DRV/r) with dolutegravir (DTG) or dolutegravir with tenofovir and emtricitabine or lamivudine (DTG+2NRTI) will provide non-inferior antiretroviral efficacy over 48 weeks compared with WHO-recommended standard of care (SOC) therapy of 2NRTIs plus a ritonavir-boosted PI.Timepoint: Time points in this study are Week 4, Week 12, Week 24, Week 48 and Week 96
- Secondary Outcome Measures
Name Time Method ATimepoint: NA