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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Levonorgestrel-releasing intrauterine device (IUD)
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Intrauterine Device, IUD, Contraceptive, Levonorgestrel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • UCLA CARE Center CRS
  • IHV Baltimore Treatment CRS
  • SSTAR, Family Healthcare Ctr.
  • Washington U CRS
  • Beth Israel Med. Ctr., ACTU
  • Duke Univ. Med. Ctr. Adult CRS
  • Rhode Island Hosp.
  • The Miriam Hosp. ACTG CRS
  • Puerto Rico-AIDS CRS

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 12, 2004
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00096694
Brief Title
Effect of an Intrauterine Contraceptive Device (IUD) in HIV Infected Women
Official Title
A Pilot Study Evaluating the Effect of the Levonorgestrel-Releasing Intrauterine Device on Genital HIV Shedding in HIV-1-Infected Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Intrauterine Device, IUD, Contraceptive, Levonorgestrel

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Levonorgestrel-releasing intrauterine device (IUD)
Primary Outcome Measure Information:
Title
Sign and magnitude of difference in endocervical HIV viral load from baseline to Week 4 post-IUD insertion
Title
incidence of discontinuation of IUD use in the year following insertion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. Milu Kojic, MD
Organizational Affiliation
Department of Immunology/Infectious Disease, The Miriam Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA CARE Center CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
77555-0435
Country
United States
Facility Name
IHV Baltimore Treatment CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
SSTAR, Family Healthcare Ctr.
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Beth Israel Med. Ctr., ACTU
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Duke Univ. Med. Ctr. Adult CRS
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Rhode Island Hosp.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
The Miriam Hosp. ACTG CRS
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Puerto Rico-AIDS CRS
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
15193636
Citation
Bird ST, Harvey SM, Maher JE, Beckman LJ. Acceptability of an existing, female-controlled contraceptive method that could potentially protect against HIV: a comparison of diaphragm users and other method users. Womens Health Issues. 2004 May-Jun;14(3):85-93. doi: 10.1016/j.whi.2004.03.003.
Results Reference
background
PubMed Identifier
10546862
Citation
Richardson BA, Morrison CS, Sekadde-Kigondu C, Sinei SK, Overbaugh J, Panteleeff DD, Weiner DH, Kreiss JK. Effect of intrauterine device use on cervical shedding of HIV-1 DNA. AIDS. 1999 Oct 22;13(15):2091-7. doi: 10.1097/00002030-199910220-00012.
Results Reference
background
PubMed Identifier
14719851
Citation
Stuart GS, Castano PM. Sexually transmitted infections and contraceptives: selective issues. Obstet Gynecol Clin North Am. 2003 Dec;30(4):795-808. doi: 10.1016/s0889-8545(03)00074-3.
Results Reference
background
PubMed Identifier
15075537
Citation
Wang CC, McClelland RS, Overbaugh J, Reilly M, Panteleeff DD, Mandaliya K, Chohan B, Lavreys L, Ndinya-Achola J, Kreiss JK. The effect of hormonal contraception on genital tract shedding of HIV-1. AIDS. 2004 Jan 23;18(2):205-9. doi: 10.1097/00002030-200401230-00009.
Results Reference
background

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

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