Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096694
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2004-11-12
Brief Title:
Effect of an Intrauterine Contraceptive Device IUD in HIV Infected Women
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Study Evaluating the Effect of the Levonorgestrel-Releasing Intrauterine Device on Genital HIV Shedding in HIV-1-Infected Women
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womans 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 womans 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
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 womans 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 womans 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 participants 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
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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10187 | REGISTRY | None | None |
| ACTG A5205 | Registry Identifier | DAIDS ES | None |