The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception (NET)
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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 |
- 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 |
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| Contact: Jessica M Atrio, MD | 917-721-6155 | jessicaatrio@gmail.com |
| Contact: Blanca Ovalle | 323-896-6115 | blanca.ovalle@med.usc.edu |
| 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 | |
| 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:
|
HIV contraception mini pill norethindrone atazanavir ritonavir norvir |
reyataz pregnancy prevent birth control 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 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 HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents |
ClinicalTrials.gov processed this record on May 19, 2013