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
|
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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 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 |

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
|
- 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 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

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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

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
United States, California | |
Covance Cpu, Inc | |
San Diego, California, United States, 92123 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
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 |