Drug Interaction Study Between Dolutegravir and an Oral Contraceptive Containing Norgestimate and Ethinylestradiol
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
Dolutegravir (DTG, GSK1349572 is an integrase inhibitor that is currently in Phase 3 clinical
development for the treatment of HIV infection. DTG will likely be used in women on oral
contraceptives (OC) for birth control. Based on accumulated non-clinical and clinical drug
metabolism and pharmacokinetic data, there is a low likelihood of drug interaction between
DTG and most widely used OC drugs. The primary objective of this study is to evaluate the
effect of DTG administration on the pharmacokinetics and pharmacodynamics of a commonly used
oral contraceptive product, Ortho-Cyclen (combination of norgestimate and ethinyl estradiol),
in healthy female subjects. Each subject will participate in a Run-in period (if needed),
followed by two treatment periods. Approximately 16 subjects will be randomized in a
cross-over fashion to either Ortho-Cyclen with DTG or Ortho-Cyclen with Placebo for 10 days
and switch to the alternate treatment for another 10 days. Subjects will return to the study
center for final follow up evaluations 7 - 14 days after the final dose of study medication.