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Comparison of Two IUDs Among Cape Town HIV-positive Women

Information source: FHI 360
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV

Intervention: Mirena levonorgestrel IUD (Device); Copper T-380a IUD (Device)

Phase: N/A

Status: Recruiting

Sponsored by: FHI 360

Official(s) and/or principal investigator(s):
B Landon Myer, MBChB, PhD, Principal Investigator, Affiliation: University of Cape Town

Overall contact:
Catherine Todd, MD, MPH, Phone: 01166849790115, Email: ctodd@fhi360.org

Summary

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.

Clinical Details

Official title: Comparison of Two IUDs Among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: change in genital tract HIV shedding (measured through viral load)

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

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

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:

-

Locations and Contacts

Catherine Todd, MD, MPH, Phone: 01166849790115, Email: ctodd@fhi360.org

University of Cape Town, Cape Town, Western Cape Province 7701, South Africa; Recruiting
B Landon Myer, MBChC, PhD, Phone: 01127214066661, Email: Landon.Myer@uct.ac.za
B Landon Myer, MBChB, PhD, Principal Investigator
Additional Information

Starting date: November 2013
Last updated: August 18, 2015

Page last updated: August 23, 2015

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