HIV InfectionsNCT00096694
Effect of an Intrauterine Contraceptive Device (IUD) in HIV Infected Women
A study testing Levonorgestrel-releasing intrauterine device (IUD) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Levonorgestrel-releasing intrauterine device (IUD)
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Start not givento Sep 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
IHV Baltimore Treatment CRS
Baltimore, Maryland, 21201
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina
SSTAR, Family Healthcare Ctr.
Fall River, Massachusetts, 02720
UCLA CARE Center CRS
Los Angeles, California, 77555-0435
Beth Israel Med. Ctr., ACTU
New York, New York, 10003
Rhode Island Hosp.
Providence, Rhode Island, 02906
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, 02906
Washington U CRS
St Louis, Missouri
About this study
Official title: A Pilot Study Evaluating the Effect of the Levonorgestrel-Releasing Intrauterine Device on Genital HIV Shedding in HIV-1-Infected Women
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Levonorgestrel-releasing intrauterine device (IUD)
- Keywords
- Intrauterine Device, IUD, Contraceptive, Levonorgestrel
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel-releasing intrauterine device (IUD)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2004 (estimated)
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- E. Milu Kojic, MD, Study chair, Department of Immunology/Infectious Disease, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096694
- Sponsor's protocol ID
- A5205
- Other IDs
- 10187, ACTG A5205
- Status last verified
- Oct 2021
- First submitted
- 12 Nov 2004
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
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.
PubMed 15193636Richardson 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.
PubMed 10546862Stuart 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.
PubMed 14719851Wang 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.
PubMed 15075537
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Effect of the Levonorgestrel-Releasing Intrauterine Device on Genital HIV Shedding in HIV-1-Infected Women
- ClinicalTrials.gov ID
- NCT00096694
- Acronym / sponsor ID
- A5205
- Conditions
- HIV Infections
- Keywords
- Intrauterine Device, IUD, Contraceptive, Levonorgestrel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Sep 2005 (actual)
- First posted
- 15 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgestrel-releasing intrauterine device (IUD) | Device | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Background: PubMed 15193636Bird 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.
- Background: PubMed 10546862Richardson 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.
- Background: PubMed 14719851Stuart 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.
- Background: PubMed 15075537Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E. Milu Kojic, MD study chair
Department of Immunology/Infectious Disease, The Miriam Hospital
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levonorgestrel-releasing intrauterine device (IUD) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sign and magnitude of difference in endocervical HIV viral load from baseline to Week 4 post-IUD insertion. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00096694, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.