Clinical Trials Logo

Clinical Trial Summary

GSK has in-licensed a novel NNRTI-class candidate (GSK2248761, IDX12899) for the treatment of subjects with HIV-1 infection from Idenix Pharmaceuticals. Idenix Pharmaceuticals completed a proof-of-concept study evaluating GSK2248761 monotherapy over seven days in forty treatment-naïve subjects infected with HIV-1. GSK2248761 doses sequentially evaluated were 800 mg QD, 400 mg QD, 200 mg QD and 100mg QD.

This study will evaluate a lower dose, or doses, of GSK2248761 to better characterize the dose-response and concentration-response curves. The results from this study will be used to select doses for future clinical studies in HIV-1 infected subjects.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT00945282
Study type Interventional
Source ViiV Healthcare
Contact
Status Completed
Phase Phase 2
Start date October 20, 2009
Completion date November 28, 2009

See also
  Status Clinical Trial Phase
Completed NCT01425099 - Drug Interaction Study Between Dolutegravir and Prednisone Phase 1
Completed NCT01209117 - A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435 Phase 1
Completed NCT03231943 - GSK3640254 First Time in Human (FTIH) Study in Healthy Volunteers Phase 1
Terminated NCT01195974 - A Study to Evaluate the Pharmacokinetics of an Oral Contraceptive When Co-administered With GSK2248761 in Healthy Adult Female Subjects. Phase 1
Completed NCT02893488 - Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet Phase 1
Terminated NCT01199731 - Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection Phase 2
Completed NCT01449929 - Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects Phase 3
Active, not recruiting NCT02951052 - Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults Phase 3
Completed NCT01231516 - A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults Phase 3
Completed NCT02273947 - Food Effect Study With BMS-955176 Phase 1
Completed NCT00071760 - Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects Phase 2
Completed NCT02539576 - Pharmacokinetics, Safety and Tolerability Study of Abacavir/ Dolutegravir/ Lamivudine Fixed-dose Combination Tablets in Healthy Japanese Subjects Phase 1
Completed NCT01967771 - Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects Phase 1
Completed NCT01077635 - PENTA Fosamprenavir Study N/A
Completed NCT00774735 - GSK1349572 Drug Interaction Study With Protease Inhibitors Phase 1
Completed NCT00386347 - A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects. Phase 1
Terminated NCT02576119 - A Study to Determine the Effect of Multiple Doses of BMS-955176 on the Electrocardiograph of Healthy Subjects Phase 1
Completed NCT02277600 - A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI) Phase 1
Completed NCT01077557 - Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status N/A
Completed NCT00398125 - Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults Phase 2