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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-11-30

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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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A1

Group Type ACTIVE_COMPARATOR

Ortho Tri-Cyclen (ethinyl estradiol + norgestimate)

Intervention Type DRUG

Tablets, Oral, 35 mcg of EE + 0.18/0.215/0.25 mg of NGM, once daily, 28 days.

A2

Group Type EXPERIMENTAL

Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days

Intervention Type DRUG

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.

Interventions

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Ortho Tri-Cyclen (ethinyl estradiol + norgestimate)

Tablets, Oral, 35 mcg of EE + 0.18/0.215/0.25 mg of NGM, once daily, 28 days.

Intervention Type DRUG

Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days

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.

Intervention Type DRUG

Other Intervention Names

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Reyataz

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes