Effect of an Intrauterine Contraceptive Device (IUD) in HIV Infected Women

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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 transmitting HIV to sexual partners. Levonorgestrel is commonly prescribed as part of a combination OC. An intrauterine device (IUD) is a device inserted in a woman's uterus to prevent pregnancy. The purpose of this study is to determine the effect of a levonorgestrel-releasing IUD on the amount of HIV present in an HIV infected woman's cervix after 4 weeks of IUD use. Study hypothesis: There will be no increase in genital tract HIV RNA and DNA after placement of the levonorgestrel IUD.

Key facts

Study ID

NCT00096694

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

41

Expected to finish

2005-09-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA CARE Center CRS — Los Angeles, California, United States
• IHV Baltimore Treatment CRS — Baltimore, Maryland, United States
• SSTAR, Family Healthcare Ctr. — Fall River, Massachusetts, United States
• Washington U CRS — St Louis, Missouri, United States
• Beth Israel Med. Ctr., ACTU — New York, New York, United States
• Duke Univ. Med. Ctr. Adult CRS — Durham, North Carolina, United States
• Rhode Island Hosp. — Providence, Rhode Island, United States
• The Miriam Hosp. ACTG CRS — Providence, Rhode Island, United States
• Puerto Rico-AIDS CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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