Last reviewed · How we verify
The Effect of the Co-administration of Atazanavir (ATV) and Ritonavir (RTV) on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects
The purpose of this study is to administer a combined oral contraceptive (ethinyl estradiol and norgestimate) with the HIV treatment of atazanavir and ritonavir to healthy females in order to assess if the concentrations of the oral contraceptive change. The safety of this treatment regimen will also be studied.
Details
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 22 |
| Start date | 2006-07 |
| Completion | 2006-11 |
Conditions
- HIV Infections
Interventions
- Ortho Tri-Cyclen (ethinyl estradiol + norgestimate)
- Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days
Primary outcomes
- To determine the effect of co-administration of atazanavir 300 mg and ritonavir 100 mg on the pharmacokinetics of ethinyl estradiol
Countries
United States