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

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Completed

Conditions

HIV Infections

Treatments

Device: Levonorgestrel-releasing intrauterine device (IUD)

Study type

Interventional

Funder types

NIH

Identifiers

NCT00096694

A5205

10187 (Registry Identifier)

ACTG A5205

Details and patient eligibility

About

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.

Full 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 higher doses of OCs may increase cervical shedding of HIV-1, which may increase an HIV infected woman's infectiousness to her sexual partners. A physical barrier contraceptive would be useful to HIV infected women to circumvent the problems associated with concurrent use of OCs and ART. The levonorgestrel IUD has proved highly effective in preventing unwanted pregnancies in HIV uninfected women since its introduction in the United States in 1999. This study will evaluate the effect of the levonorgestrel IUD on HIV viral load in an HIV infected woman's cervix after 4 weeks of IUD use.

This study will last approximately 48 weeks; there will be 4 study visits. At screening, participants will undergo medical and medication history assessment; a complete physical exam; a pelvic exam, including genital tract sample collection; blood collection; sexually transmitted disease (STD) testing; and a Pap smear, if needed. The levonorgestrel IUD will be inserted into the participant's uterus at study entry. At study entry and at Weeks 4, 16, and 48, participants will undergo a targeted physical exam; a pelvic exam, including genital tract sample collection; and blood collection. Participants will be given a menstrual diary at the start of the study and at each study visit and will be asked to document all menstrual cycles they have for the duration of the study.

To be eligible for this study, participants may not have had ART within 90 days prior to study entry. However, after the Week 4 study visit, participants may reinitiate (if they were on ART more than 90 days prior to study entry) or initiate (if they are ART naive) ART, if deemed necessary to do so by their physicians.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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