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

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: July 26, 2006
Last updated: April 7, 2011
Last verified: June 2008
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.

Condition Intervention Phase
HIV Infections
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
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To determine the effect of co-administration of atazanavir 300 mg and ritonavir 100 mg on the pharmacokinetics of ethinyl estradiol

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 22
Study Start Date: July 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1 Drug: 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.
Experimental: A2 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.
Other Name: Reyataz


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00357604

United States, California
Covance Cpu, Inc
San Diego, California, United States, 92123
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information: Identifier: NCT00357604     History of Changes
Other Study ID Numbers: AI424-285
Study First Received: July 26, 2006
Last Updated: April 7, 2011

Keywords provided by Bristol-Myers Squibb:
Protease Inhibitor

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Atazanavir Sulfate
Norgestimate, ethinyl estradiol drug combination
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Contraceptives, Oral
Ethinyl Estradiol
Polyestradiol phosphate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents processed this record on May 25, 2017