Comparison of 2 IUDnCT Devices
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Purpose
This study will inform international medical guidelines as to whether the Levonorgestrel intrauterine device (LNG IUD), a highly effective long-acting reversible contraceptive method, is safe and acceptable as compared to the copper intrauterine device (C-IUD) for HIV-positive women in Cape Town, South Africa. If the LNG IUD is found to be safe and acceptable, the introduction of this method to HIV positive women in developing countries could significantly reduce unplanned pregnancy and mother-to-child transmission of HIV, and confer non-contraceptive benefits to HIV-positive women in Sub-Saharan Africa.
| Condition | Intervention |
|---|---|
|
Comparing Safety With Regard to HIV Disease Progression and Acceptability of Levonorgestrel IUD to the Copper IUD Among HIV-infected ART-naïve Women. |
Device: Mirena levonorgestrel IUD and copper T-380a IUD |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Two IUDs Among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa |
- change in plasma viral load and time to ART initiation between HIV-positive ART-naive women using the levonorgestrel IUD and those using the copper IUD over 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]change in plasma viral load and time to ART initiation between HIV-positive ART-naive women using the levonorgestrel IUD and those using the copper IUD over 24 months.
- change in genital tract HIV shedding (measured through viral load) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- IUD continuation rates between HIV-positive ART-naive women using the levonorgestrel IUD and those using the copper IUD over 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 324 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | April 2017 |
| Estimated Primary Completion Date: | April 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 2
Copper IUD
|
Device: Mirena levonorgestrel IUD and copper T-380a IUD
Intrauterine contraceptive devices
|
|
Active Comparator: 1
Levonorgestrel IUD
|
Device: Mirena levonorgestrel IUD and copper T-380a IUD
Intrauterine contraceptive devices
|
Detailed Description:
Design: Single site, double-blind, randomized controlled trial
Population: Antiretroviral therapy ineligible, HIV-positive South African women between the ages of 18 and 40 years
Study size: 324 women
Study intervention: Levonorgestrel intrauterine device (LNG IUD) or the copper T-380 intrauterine device (C-IUD)
Duration & Follow-up: Approximately 42 months in total. Recruitment will take approximately 18 months. After enrollment, each participant will be followed for 24 months.
Primary Objectives: To compare LNG IUD safety to the safety of the C-IUD by comparing HIV progression between the two study arms.
Secondary Objectives: 1) To measure LNG IUD safety with respect to genital viral load shedding, a surrogate for HIV infectivity, as compared to the C-IUD. 2) To measure LNG IUD acceptability through device continuation and other measures as compared to the C-IUD.
Primary Endpoints: HIV-1 Viral Load (VL) change, CD4 change, hemoglobin change, time to antiretroviral therapy (ART) initiation, incidence of sexually-transmitted infections (STIs) and pelvic inflammatory disease (PID)
Secondary Endpoints: 1) Initiation/acceleration of detectable HIV RNA genital shedding 2) IUD continuation and expulsion rates and acceptability measures through quantitative and qualitative methods
Study Site: Gugulethu Community Health Centre (GCHC), Cape Town, South Africa
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Willing and able to provide written informed consent (IC) to be screened for and to participate in the trial
- Interested and willing to use the IUD as a family planning method.
- Women between 18 to 40 years (inclusive).
Willing to participate in all aspects of the study and to comply with study procedures and visits, for 24 months, including:
- Be randomized
- Adhere to follow-up schedule and willing to be contacted by site staff between study visits (by phone and/or in person)
- Provide contact/locator information
- Agree for site staff to review clinic chart to confirm HIV status
- Have documented HIV infection.
- Have a CD4 count >500 cells/mm3 in last 3 months.
- Be at least 6 months post-pregnancy and not pregnant or desiring pregnancy for the next 30 months.
- Intending residence in Cape Town area for next 30 months.
- No documented or known history of infertility or sterilization.
- Atypical squamous cells of undetermined significance (ASCUS), low-grade squamous intraepithelial lesion (LSIL), or normal cervical cytology within the last 36 months.
- No history of or suspected hormonally-dependent neoplasm or undiagnosed abnormal vaginal bleeding.
- Local language fluency and comprehension.
- No history of adverse reaction to latex
- Not participating in any other clinical trial with a biomedical intervention
- Have no condition that, based on the opinion of the Site PI, would preclude provision of informed consent, make participation in the study unsafe or complicate interpretation of data.
Exclusion Criteria:
-
Contacts and Locations| Contact: Catherine Todd, MD, MPH | 01166849790115 | ctodd@fhi360.org |
| South Africa | |
| University of Cape Town | Not yet recruiting |
| Cape Town, Western Cape Province, South Africa, 7701 | |
| Contact: B Landon Myer, MBChC, PhD 01127214066661 Landon.Myer@uct.ac.za | |
| Principal Investigator: B Landon Myer, MBChB, PhD | |
| Principal Investigator: | B Landon Myer, MBChB, PhD | University of Cape Town |
More Information
No publications provided
| Responsible Party: | FHI 360 |
| ClinicalTrials.gov Identifier: | NCT01721798 History of Changes |
| Other Study ID Numbers: | 10369 |
| Study First Received: | October 18, 2012 |
| Last Updated: | November 2, 2012 |
| Health Authority: | South Africa: Medical Research Council South Africa: University of Capetown IRB United States: National institutes of Health United States: FHI360 PHSC |
Keywords provided by FHI 360:
|
AE adverse event AIDS acquired immunodeficiency syndrome ALT (SGPT) alanine aminotransferase ART antiretroviral therapy AST (SGOT) aspartate aminotransferase DCF data collection forms DMC Data Monitoring Committee FDA (U.S.) Food and Drug Administration GCP Good Clinical Practice guidelines HB sAg Hepatitis B surface antigen ICH International Conference of Harmonization |
IND Investigational New Drug Application IRB Institutional Review Board IU International units mg milligram(s) mm3 cubic millimeter(s) PCR polymerase chain reaction SAE serious adverse event µg microgram ULN upper limit of the normal range WB Western Blot |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Disease Progression Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Disease Attributes Pathologic Processes |
Copper Levonorgestrel Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on February 28, 2013
