The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception

NCT01667978 | Completed Results

• 1 other identifier: HS-12-00005
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pregnancy; HIV; AIDS

Keywords

contraception; mini pill; norethindrone; atazanavir; ritonavir; norvir; reyataz; pregnancy prevent; birth control; HIV; AIDS; antiviral; antiretroviral

Outcome Measures

Primary Outcomes (1)

• AUC Norethindrone

  0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 21

  following 21 days of continuous ingestion

Study Arms (2)

PI

EXPERIMENTAL

Study group with PI: atazanavir ritonavir

Drug: Norethindrone acetate

Control

PLACEBO COMPARATOR

o PI therapy, control group

Drug: Norethindrone acetate

Interventions

Norethindrone acetate DRUG

Also known as: Both control and experimental group with take norethindrone. However the experimental group will be taking a protease inhibitor: atazanavir and ritonavir

Control; PI

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• Society of Family Planning: collaborator

Study Sites (2)

Los Angeles County Hospital University of Southern California (LAC USC)

Los Angeles, California, 90033-1029, United States

Location

Los Angeles County University of Southern California

Los Angeles, California, 90033-1029, United States

Location

Related Publications (2)

• Atrio J, Stek A, Vora H, Sanchez-Keeland L, Zannat F, Natavio M. The effect of protease inhibitors on the cervical mucus of HIV-positive women taking norethindrone contraception. Eur J Contracept Reprod Health Care. 2015 Apr;20(2):149-53. doi: 10.3109/13625187.2014.957826. Epub 2014 Oct 6.

  PMID: 25285572 DERIVED

• DuBois BN, Atrio J, Stanczyk FZ, Cherala G. Increased exposure of norethindrone in HIV+ women treated with ritonavir-boosted atazanavir therapy. Contraception. 2015 Jan;91(1):71-5. doi: 10.1016/j.contraception.2014.08.009. Epub 2014 Aug 30.

  PMID: 25245190 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Norethindrone Acetate; Ritonavir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Norethindrone; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jessica Atrio
• Organization: Montefiore

jatrio@montefiore.org

718 405 82 60

Study Officials

• Jessica M Atrio, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: August 17, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2014
• Last Updated: August 20, 2015
• Results First Posted: August 20, 2015

Record last verified: 2015-08

Locations

US (2)