NCT00096694

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for not_applicable hiv-infections

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

November 12, 2004

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

Intrauterine DeviceIUDContraceptiveLevonorgestrel

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

Levonorgestrel-releasing intrauterine device (IUD)DEVICE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UCLA CARE Center CRS

Los Angeles, California, 77555-0435, United States

Location

IHV Baltimore Treatment CRS

Baltimore, Maryland, 21201, United States

Location

SSTAR, Family Healthcare Ctr.

Fall River, Massachusetts, 02720, United States

Location

Washington U CRS

St Louis, Missouri, United States

Location

Beth Israel Med. Ctr., ACTU

New York, New York, 10003, United States

Location

Duke Univ. Med. Ctr. Adult CRS

Durham, North Carolina, United States

Location

Rhode Island Hosp.

Providence, Rhode Island, 02906, United States

Location

The Miriam Hosp. ACTG CRS

Providence, Rhode Island, 02906, United States

Location

Puerto Rico-AIDS CRS

San Juan, Puerto Rico

Location

Related Publications (4)

  • 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.

    PMID: 15193636BACKGROUND

  • 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.

    PMID: 10546862BACKGROUND

  • 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.

    PMID: 14719851BACKGROUND

  • 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.

    PMID: 15075537BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • E. Milu Kojic, MD

    Department of Immunology/Infectious Disease, The Miriam Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2004

First Posted

November 15, 2004

Study Completion

September 1, 2005

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(8)PR(1)