Atazanavir and Ritonavir (ATV/RTV) and an Oral Contraceptive in Healthy Females

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Ortho Tri-Cyclen (ethinyl estradiol + norgestimate)
* Drug: Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women of childbearing potential with intact ovarian function who have been on a stable regimen of oral contraceptives for at least 2 months prior to beginning the study Documented acceptable Pap smear within 1 year prior to dosing Body mass index (BMI) 18-32 kg/m2 Exclusion Criteria: Males Subjects with an abnormal menstrual cycle during the 2 months prior to the start of the study or during the lead-in period (breakthrough bleeding/spotting) History of conditions where the use of oral contraceptives are contraindicated Known or suspected carcinoma or suspected estrogen dependent neoplasia History of migraine with focal aura History of uncontrolled hypertension Positive screening test for HIV-1, -2, HIV viral ribonucleic acid (RNA), hepatitis B surface antigen, or hepatitis C antibody

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1<br> | Drug: Ortho Tri-Cyclen (ethinyl estradiol + norgestimate)<br>* Tablets, Oral, 35 mcg of EE + 0.18/0.215/0.25 mg of NGM, once daily, 28 days.<br>|
| Experimental: A2<br> | Drug: Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days<br>* Tablets + Capsules/Capsules, Oral, (25 mcg of EE + 0.18/0.215/0.25 mg of NGM) + 300/100 mg then 35 mcg of EE + 0.18/0.215/0.25 mg of NGM, once daily, 21 days.<br>* Other names: Reyataz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of co-administration of atazanavir 300 mg and ritonavir 100 mg on the pharmacokinetics of ethinyl estradiol |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of the co-administration of atazanavir 300 mg and ritonavir 100 mg on the pharmacokinetics (PK) of 17-deacetyl norgestimate |  |  | 
| To assess the safety of atazanavir 300 mg and ritonavir 100 mg co-administered with the oral contraceptive Ortho Tri-Cyclen LO |  |  | 
| To characterize the PK of atazanavir and ritonavir during co-administration with Ortho Tri-Cyclen LO |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Protease Inhibitor