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

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ClinicalTrials.gov Identifier: NCT00357604
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : April 8, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  1. To determine the effect of the co-administration of atazanavir 300 mg and ritonavir 100 mg on the pharmacokinetics (PK) of 17-deacetyl norgestimate
  2. To assess the safety of atazanavir 300 mg and ritonavir 100 mg co-administered with the oral contraceptive Ortho Tri-Cyclen LO
  3. To characterize the PK of atazanavir and ritonavir during co-administration with Ortho Tri-Cyclen LO

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

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357604


Locations
United States, California
Covance Cpu, Inc
San Diego, California, United States, 92123
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00357604     History of Changes
Other Study ID Numbers: AI424-285
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: June 2008

Keywords provided by Bristol-Myers Squibb:
HIV
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
Ritonavir
Atazanavir Sulfate
Moxifloxacin
Fluoroquinolones
Estradiol
Polyestradiol phosphate
 Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Norgestimate
Norgestrel
Norgestimate, ethinyl estradiol drug combination
Contraceptives, Oral
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents