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Protocol Summaries: cabotegravir

ViiV
Study ID
   Phase    Title Status
116482 phase 2 A Phase IIb, dose ranging study of oral GSK1265744 in combination with nucleoside reverse transcriptase inhibitors for induction of human immunodeficiency virus -1 (HIV-1) virologic suppression followed by an evaluation of maintenance of virologic suppression when oral GSK1265744 is combined with oral rilpivirine in HIV-1 infected, antiretroviral therapy naive adult subjects Active not recruiting
117010 Phase 1 Phase I, single-center, open label, fixed-sequence cross-over study to evaluate the effect of rifampin on the pharmacokinetics of oral cabotegravir in healthy subjects Completed
200056 phase 2 A Phase IIb Study Evaluating a Long-Acting Intramuscular Regimen of GSK1265744 plus TMC278 For The Maintenance of Virologic Suppression Following an Induction of Virologic Suppression on an Oral regimen of GSK1265744 plus Abacavir/Lamivudine in HIV-1 Infected, Antiretroviral Therapy-Naive Adult Subjects Active not recruiting
201120 phase 2 A Phase IIa Study to Evaluate the Safety, Tolerability and Acceptability of Long Acting Injections of the HIV Integrase Inhibitor, GSK1265744, in HIV Uninfected Men (ECLAIR) Completed
201479 Phase 1 A Phase I Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 in Subjects with Hepatic Impairment and Healthy Matched Control Subjects Completed
201480 Phase 1 A Phase I, Open-Label, Parallel-Group Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 in Subjects with Severe Renal Impairment and Healthy Matched Control Subjects Completed
201584 phase 3 A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch from an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants Active, not recruiting
201585 phase 3 A Phase III, randomized, multicenter, parallel-group, non-inferiority, open-label study evaluating the efficacy, safety, and tolerability of switching to long-acting cabotegravir plus long-acting rilpivirine from current INI- NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed Recruiting
201741 phase 1 A Phase 1, single-center, randomized, open-label, crossover study to assess the relative bioavailability of Phase III tablet formulation candidates in healthy adult subjects Completed
201767 phase 1 A Phase 1, Multicompartmental Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers Not yet recruiting
205162 PGX7646: Evaluation of relationships between UGT1A1 and UGT1A9 genotypes and cabotegravir pharmacokinetics and tolerability Completed
205696 Phase 1 A Phase I study evaluating the effect of a high fat meal on the pharmacokinetics of cabotegravir in healthy adult volunteers Completed
205712 phase 1 Phase I, single-center, open label, fixed-sequence cross-over study to evaluate the effect of rifabutin on the pharmacokinetics of oral cabotegravir in healthy subjects Recruiting