Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women

NCT01721798 | Completed Results DMC

• 1 other identifier: 10369
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV

Keywords

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 Council for 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

Outcome Measures

Primary Outcomes (1)

• Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL)

  Number of women with detectable genital tract HIV RNA as measured with menstrual cup sampling at each scheduled visit. Level of detection was 20-40 copies/mL depending on assay; outcome was dichotomous with copies above level of detection coded as detectable and those below level of detection considered undetectable.

  Enrollment to 24 months

Secondary Outcomes (4)

• Participants With Detectable Plasma HIV Ribonucleic Acid (RNA) Viral Load Among Those Using Antiretroviral Therapy (ART)

  Enrollment to 24 months

• Mean Hemoglobin Concentration as Part of Intrauterine Contraceptive Safety

  Enrollment to 24 months

• Participants Continuing Use of the Allocated Intrauterine Device (IUD)

  Enrollment to 24 months

• HIV Ribonucleic Acid (RNA) Concentration by Lower Female Genital Tract Sampling Method

  6 months

Study Arms (2)

Copper T-380a Intrauterine Device (C-IUD)

ACTIVE COMPARATOR

Copper T-380A Intrauterine Device with approximately 380 mm2 exposed copper. Devices used were those included as part of the South African public sector health formulary.

Device: Copper T-380a IUD

Levonorgestrel IUD (LNG-IUD)

ACTIVE COMPARATOR

Levonorgestrel IUD containing 52 mg levonorgestrel registered for contraceptive use in South Africa at the time of the trial.

Device: Mirena levonorgestrel IUD

Interventions

Mirena levonorgestrel IUD DEVICE

Intrauterine contraception system

Levonorgestrel IUD (LNG-IUD)

Copper T-380a IUD DEVICE

intrauterine contraception system

Copper T-380a Intrauterine Device (C-IUD)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 intrauterine device (IUD) as a family planning method.
• Between 18 to 40 years of age (inclusive): This age range includes women during their years of greatest fertility and 18 is the age of majority for research consent in South Africa.
• 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
• Has documented HIV infection
• For pre-antiretroviral therapy (ART) entrants:
• ART-ineligible at screening, based on current South African ART guidelines
• Be at least 6 months post-delivery and not pregnant or desiring pregnancy for the next 30 months.
• For ART-using entrants:
• ART-use demonstrated by clinical records reflecting laboratory measures consistent with ART use and evidence of viral suppression (plasma viral load (VL)\<1000 copies/mL) at the most recent VL measure.
• Be at least 6 weeks post-delivery and not pregnant or desiring pregnancy for the next 30 months.

You may not qualify if:

• Known congenital or acquired uterine anomaly including fibroids distorting the uterine cavity;
• Known acute liver disease or hepatic neoplasm;
• Known copper storage disease;
• Known hypersensitivity to any component of the levonorgestrel IUD (LNG IUD) or copper IUD (C-IUD) or latex allergy
• Pregnant or desiring pregnancy in next 24 months
• Gross cervical lesion concerning for neoplasia
• CD4 lymphocyte count\<350 cells/mm3 if not using ART
• Less than 6 weeks postpartum

Sponsors & Collaborators

• FHI 360: lead
• University of Cape Town: collaborator
• City University of New York, School of Public Health: collaborator

Study Sites (1)

University of Cape Town

Cape Town, Western Cape, 7701, South Africa

Location

Related Publications (2)

• Langwenya N, Todd CS, Jones HE, Hoover DR, Hu NC, Ronan A, Myer L. Risk-based screening to identify reproductive tract infection among HIV-infected women desiring use of intrauterine contraceptives. BMJ Sex Reprod Health. 2021 Apr;47(2):137-143. doi: 10.1136/bmjsrh-2019-200494. Epub 2020 Jul 1.

  PMID: 32611546 DERIVED

• Todd CS, Jones HE, Langwenya N, Hoover DR, Chen PL, Petro G, Myer L. Safety and continued use of the levonorgestrel intrauterine system as compared with the copper intrauterine device among women living with HIV in South Africa: A randomized controlled trial. PLoS Med. 2020 May 22;17(5):e1003110. doi: 10.1371/journal.pmed.1003110. eCollection 2020 May.

  PMID: 32442189 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Catherine Todd
• Organization: FHI 360

ctodd@fhi360.org

+1-919-544-7040

Study Officials

• B Landon Myer, MBChB, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

• Catherine Todd, MD, MPH

  FHI 360

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: November 6, 2012
• Study Start: November 10, 2013
• Primary Completion: July 13, 2018
• Study Completion: July 13, 2018
• Last Updated: February 5, 2024
• Results First Posted: February 5, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)