Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
A Phase I, Open Label, Randomized, Three Period, Fixed Sequence Crossover Study to Evaluate the Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects (200901)
This study will be a phase I, open label, three period, fixed sequence crossover study to evaluate the effect of Carbamazepine (CBZ) on the steady-state pharmacokinetics of Dolutegravir (DTG) and on the safety and tolerability of DTG. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There is no washout between treatment periods.
n/a
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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 |
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 | |
Completed |
NCT00945282 -
Safety and Tolerability Study to Evaluate Lower Dose of GSK2248761 in Antiretroviral Treatment-Naive HIV-1 Infected Adults.
|
Phase 2 | |
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 |
NCT00398125 -
Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults
|
Phase 2 | |
Completed |
NCT01077557 -
Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status
|
N/A |