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

This study is currently recruiting participants.
Verified December 2013 by FHI 360
Sponsor:
Collaborators:
University of Cape Town
The City University of New York
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01721798
First received: October 18, 2012
Last updated: December 30, 2013
Last verified: December 2013
  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
HIV
Device: Mirena levonorgestrel IUD
Device: 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

Resource links provided by NLM:


Further study details as provided by FHI 360:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • change in genital tract HIV shedding (measured through viral load) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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: November 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: Copper T-380a IUD
Copper T-380a IUD
Device: Mirena levonorgestrel IUD
Intrauterine contraceptive devices
Active Comparator: Mirena Levonorgestrel IUD
Mirena levonorgestrel IUD
Device: Copper T-380a IUD
intrauterine contraceptive device

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
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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721798

Contacts
Contact: Catherine Todd, MD, MPH 01166849790115 ctodd@fhi360.org

Locations
South Africa
University of Cape Town 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         
Sponsors and Collaborators
FHI 360
University of Cape Town
The City University of New York
Investigators
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: December 30, 2013
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:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
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 April 22, 2014