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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00357604
First received: July 26, 2006
Last updated: April 7, 2011
Last verified: June 2008

July 26, 2006
April 7, 2011
July 2006
November 2006   (final data collection date for primary outcome measure)
To determine the effect of co-administration of atazanavir 300 mg and ritonavir 100 mg on the pharmacokinetics of ethinyl estradiol
To determine the effect of coadministration of atazanavir 300 mg and ritonavir 100 mg on the pharmacokinetics of ethinyl estradiol.
Complete list of historical versions of study NCT00357604 on ClinicalTrials.gov Archive Site
  • 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
  • To determine the effect of the coadministration of atazanavir 300 mg and ritonavir 100 mg on the PK of 17-deacetyl norgestimate
  • To assess the safety of atazanavir 300 mg and ritonavir 100 mg coadministered with the oral contraceptive Ortho Tri-Cyclen LO
  • To characterize the PK of atazanavir and ritonavir during coadministration with Ortho Tri-Cyclen LO
Not Provided
Not Provided
 
Atazanavir and Ritonavir (ATV/RTV) and an Oral Contraceptive in Healthy Females
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
HIV Infections
  • 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.
  • 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
  • Active Comparator: A1
    Intervention: Drug: Ortho Tri-Cyclen (ethinyl estradiol + norgestimate)
  • Experimental: A2
    Intervention: Drug: Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00357604
AI424-285
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP