At a glance
ClinicalIndex Comparison Record- ✓Male or female aged ≥18 years
- ✓Documented HIV-1 infection
- ✓Virologically suppressed with plasma HIV-RNA <50 copies/mL for >24 weeks on stable regimen
- ✓History of K103N mutation (acquired or selected); if had 100I, 101E/P, 106A/M, 138K/G/Q, 181C/I/V, 188L, 190A/S/E/Q, 230L mutations must be excluded; other NNRTI variants, all PI and NRTI mutations acceptable
- ✕HIV-2 infection
- ✕Detectable HIV-1 RNA at screening (≥50 copies/mL)
- ✕Regular dosing with H2 or PPI antacid medications, history of achlorhydria, or drugs known to interact with RPV or DTG
- ✕Medications associated with Torsades de Pointes
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Multi-Centre, Randomised, Switch Study to Evaluate the Virological Efficacy Over 96 Weeks Of 2-Drug Therapy With DTG/RPV FDC in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects Virologically Suppressed With Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Resistance Mutation K103N
In Brief
A Phase 3 clinical trial evaluating Dolutegravir & Rilpivirine 2 drug fixed dose combined therapy for HIV-1-infection. Completed, enrolled 140 participants across 29 sites in 6 countries.
Detailed Summary
HIV-1 infected subjects that experience virological failure while on non nucleoside reverse-transcriptase inhibitors (NNRTIs), including those with the K103N mutation, are usually switched to a boosted Protease Inhibitor (PI)-based regimen or other antiretroviral (ARV) combinations. The same is true for subjects who need to start antiretroviral therapy and have acquired virus that is already resistant to antiretrovirals. These "second line" combinations are often associated with numerous issues that can have a potential impact on the quality of life (QoL) of these patients. Therefore a simpler and better tolerated alternative second line treatment option would be a useful tool for the clinical management of these patients. The aim of this study is to assess the efficacy and tolerability of a dual combined therapy of Dolutegravir (DTG) 50 mg Once Daily (OD) + Rilpivirine (RPV) 25 mg OD in virologically suppressed participants with previous virological failure with NNRTIs and having the clinically significant mutation K103N. The secondary objective of the study is to assess whether a simplification of the treatment in terms of pill burden, long term metabolic toxicity and potential for drug interactions improves the QOL of the participants. The study will also evaluate DTG \& RPV concentrations in the blood plus changes in cell associated virus. In order to compare the first line treatment (boosted PI and/or other antiretroviral combinations) and the DTG+RPV combination, two thirds of study participants will be switched to DTG+RPV immediately and receive DTG+RPV for 96 weeks. The other third will be switched after 48 weeks of continuing on their first line treatment and receive DTG+RPV for 48 weeks. All participants will then be followed up for a further 30 days. Participants will be recruited from sites across Europe, and randomised onto either arm of the study. After randomisation, participants will attend approximately 10 visits over the course of two years.
Study Details
Timeline
Interventions
Daily oral tablet