Status:
COMPLETED
Effect of an Intrauterine Contraceptive Device (IUD) in HIV Infected Women
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Oral contraceptives (OCs) are not a good option for some HIV infected women because of the potential for drug interactions between OCs and anti-HIV drugs; additionally, OCs may increase the risk of tr...
Detailed Description
HIV infected women face the challenges of preventing both pregnancy and HIV transmission to their sexual partners. However, OCs may interact with antiretroviral therapy (ART), and data suggest that hi...
Eligibility Criteria
Inclusion
- HIV infected
- Willing and able to delay initiation or reinitiation of antiretroviral therapy until after Week 4 study visit
- Unlikely to develop a clinical indication to start antiretroviral therapy within 4 weeks of study entry
- CD4 count of 200 cells/mm3 or more
- Viral load of 10,000 copies/ml or more within 90 days prior to study entry
- Endocervical viral load of 2,500 copies/ml or more within 90 days prior to study entry
- History of prior pregnancy lasting at least 20 weeks
- Willing to continue any current use of hormonal contraceptives, except medroxyprogesterone acetate, until after Week 4 study visit
- Start of last menstrual period within 7 days prior to study entry
Exclusion
- Antiretroviral medications within 90 days prior to study entry
- AIDS diagnosis, including CD4 count of less than 200 cells/mm3
- Cervicitis, bacterial vaginosis, trichomoniasis, or symptomatic vaginal candidiasis within 90 days prior to study entry. Participants with any of these infections within 90 days prior to study entry are not excluded if they have received appropriate treatment and have documented resolution of the infection.
- Acute or history of pelvic inflammatory disease, chlamydia, or gonorrhea in the year prior to study entry
- Abnormal Pap smear requiring treatment in the year prior to study entry
- History of ectopic pregnancy or a condition that would predispose the participant to ectopic pregnancy
- Known uterine anomaly, including fibroids
- Known or suspected breast cancer
- Acute liver disease or liver tumor
- Have previously inserted IUD that has not been removed
- Fungal infection in the genitals
- Genital bleeding of unknown cause
- Endometritis or infected abortion within 90 days of study entry
- Known allergy or hypersensitivity to any component of the IUD used in this study
- Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study
- Serious infection or other serious medical illness that is potentially life threatening and requires systemic therapy or hospitalization within 14 days of study entry
- Use of etonogestrel and ethinyl estradiol vaginal ring (NuvaRing) within 30 days prior to study entry
- Medroxyprogesterone acetate within 90 days prior to study entry
- Pregnant or breastfeeding
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00096694
End Date
September 1 2005
Last Update
November 1 2021
Active Locations (9)
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1
UCLA CARE Center CRS
Los Angeles, California, United States, 77555-0435
2
IHV Baltimore Treatment CRS
Baltimore, Maryland, United States, 21201
3
SSTAR, Family Healthcare Ctr.
Fall River, Massachusetts, United States, 02720
4
Washington U CRS
St Louis, Missouri, United States