The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception (NET)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Southern California
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Jessica Maria Atrio, University of Southern California
ClinicalTrials.gov Identifier:
NCT01667978
First received: August 15, 2012
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to learn if women taking the atazanavir and ritonavir have lower levels of a birth control medication called norethindrone. Norethindrone (also called the mini pill) is an FDA (Food and Drug Administration) approved progestin-only birth control pill used to prevent pregnancy. Norethindrone is the standard medication used in women who take the progestin only pill to prevent pregnancy. There are other birth control pills which contain different medications. The investigators want to learn if HIV medications (atazanavir and ritonavir) make the blood level of this birth control pill higher or lower. If the levels of norethindrone are too low it may not work to prevent pregnancy. The investigators also hope to learn about changes in the vaginal fluids and cervical fluids when women are taking this birth control pill.


Condition Intervention
Pregnancy
HIV
AIDS
Drug: Norethindrone acetate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • AUC norethindrone [ Time Frame: following 21 days of continuous ingestion ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: June 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PI
Study group with PI: atazanavir ritonavir
Drug: Norethindrone acetate
Other Name: Both control and experimental group with take norethindrone. However the experimental group will be taking a protease inhibitor: atazanavir and ritonavir
Placebo Comparator: Control
o PI therapy, control group
Drug: Norethindrone acetate
Other Name: Both control and experimental group with take norethindrone. However the experimental group will be taking a protease inhibitor: atazanavir and ritonavir

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Ages: 18-44 years Gender: female Accepts: healthy volunteers and HIV-1 infected women Acceptable medications include: no other medications, NRTI combinations, entry inhibitors, integrase inhibitors, and CCR5 agonists. NRTI combinations may include but are not limited to: zidovudine (ZDV), lamivudine (3TC), emtricitabine (FTC), didanosine (ddl), stavudine (d4T), abacavir (ABC), and tenofovir disoproxil fumarate (TDF). NNRTI: etravirine, and rilpivirine.

Exclusion criteria:

History of bilateral oophorectomy, ovarian dysfunction or no regular periods. CD4+ cell count <200 cells/mm3 No current or uncontrolled thyroid, liver, or renal disease BMI <40 kg/m^2 Current pregnancy, breastfeeding or pregnancy within 30 days of enrollment. Depomedroxyprogesterone acetate injection (DMPA) within 180 days prior to study entry.

Other hormonal therapies (e.g. oral contraceptive agents, Provera, vaginal ring, contraceptive patch, monthly contraceptive injection, hormone replacement therapy, anabolic therapies, including nandrolone decanoate or megestrol acetate) within the 21 days prior to study entry.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667978

Contacts
Contact: Jessica M Atrio, MD 917-721-6155 jessicaatrio@gmail.com
Contact: Blanca Ovalle 323-896-6115 blanca.ovalle@med.usc.edu

Locations
United States, California
Los Angeles County Hospital University of Southern California (LAC USC) Recruiting
Los Angeles, California, United States, 90033-1029
Contact: Jessica M Atrio, MD    917-721-6155    jessicaatrio@gmail.com   
Los Angeles County University of Southern California Recruiting
Los Angeles, California, United States, 90033-1029
Contact: Jessica M Atrio, MD    917-721-6155    jessicaatrio@gmail.com   
Sponsors and Collaborators
University of Southern California
Society of Family Planning
Investigators
Principal Investigator: Jessica M Atrio, MD University of Southern California
  More Information

No publications provided

Responsible Party: Jessica Maria Atrio, Principle Investigator, University of Southern California
ClinicalTrials.gov Identifier: NCT01667978     History of Changes
Other Study ID Numbers: HS-12-00005
Study First Received: August 15, 2012
Last Updated: April 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
contraception
birth control
mini pill
norethindrone
atazanavir
ritonavir
norvir
reyataz
pregnancy prevent
HIV
AIDS
antiviral
antiretroviral

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Norethindrone
Norethindrone acetate
Protease Inhibitors
Ritonavir
Atazanavir
HIV Protease Inhibitors
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents

ClinicalTrials.gov processed this record on August 01, 2014