Effect of an Intrauterine Contraceptive Device (IUD) in HIV Infected Women
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|ClinicalTrials.gov Identifier: NCT00096694|
Recruitment Status : Completed
First Posted : November 15, 2004
Last Update Posted : May 21, 2012
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.
|Condition or disease||Intervention/treatment|
|HIV Infections||Device: Levonorgestrel-releasing intrauterine device (IUD)|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Evaluating the Effect of the Levonorgestrel-Releasing Intrauterine Device on Genital HIV Shedding in HIV-1-Infected Women|
|Study Completion Date :||September 2005|
- Sign and magnitude of difference in endocervical HIV viral load from baseline to Week 4 post-IUD insertion
- incidence of discontinuation of IUD use in the year following insertion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096694
|United States, California|
|UCLA CARE Center CRS|
|Los Angeles, California, United States, 77555-0435|
|United States, Maryland|
|IHV Baltimore Treatment CRS|
|Baltimore, Maryland, United States, 21201|
|United States, Massachusetts|
|SSTAR, Family Healthcare Ctr.|
|Fall River, Massachusetts, United States, 02720|
|United States, Missouri|
|Washington U CRS|
|St. Louis, Missouri, United States|
|United States, New York|
|Beth Israel Med. Ctr., ACTU|
|New York, New York, United States, 10003|
|United States, North Carolina|
|Duke Univ. Med. Ctr. Adult CRS|
|Durham, North Carolina, United States|
|United States, Rhode Island|
|Rhode Island Hosp.|
|Providence, Rhode Island, United States, 02906|
|The Miriam Hosp. ACTG CRS|
|Providence, Rhode Island, United States, 02906|
|Puerto Rico-AIDS CRS|
|San Juan, Puerto Rico|
|Study Chair:||E. Milu Kojic, MD||Department of Immunology/Infectious Disease, The Miriam Hospital|