Comparison of Two IUDs Among Cape Town HIV-positive Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by FHI 360
Sponsor:
Collaborators:
University of Cape Town
City University of New York, School of Public Health
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01721798
First received: October 18, 2012
Last updated: August 18, 2016
Last verified: August 2016
  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:
  • Compare LNG IUD safety to the safety of the C-IUD with respect to genital HIV shedding, a surrogate for potential for HIV transmission, overall and in the presence and absence of ART. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare LNG IUD safety to the safety of the C-IUD with respect to HIV progression as measured by changes in plasma viral load (VL) at 6 months between the two pre-ART study arms. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Explore LNG IUD safety with respect to non-HIV related outcomes, including hemoglobin change, incidence of sexually-transmitted infections (STIs) and pelvic inflammatory disease (PID). [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Measure LNG IUD acceptability through device continuation and other measures for the LNG IUD as compared to the C-IUD. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Compare three genital tract sampling methods to determine which provides optimal recovery of HIV RNA and immune mediators over a series of three visits. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: November 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Copper T-380a IUD
Copper T-380a IUD
Device: Copper T-380a IUD
intrauterine contraception system
Active Comparator: Mirena Levonorgestrel IUD
Mirena levonorgestrel IUD
Device: Mirena levonorgestrel IUD
Intrauterine contraception system

Detailed Description:

Design: Single site, double-blind, randomized controlled trial

Population: HIV-positive South African women between the ages of 18 and 40 years

Study size: 288 women

Study intervention: Levonorgestrel intrauterine device (LNG IUD) or the copper T-380 intrauterine device (C-IUD)

Duration & Follow-up: Approximately 48 months in total. Recruitment will take approximately 24 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 with respect to genital HIV shedding, a surrogate for potential for HIV transmission, overall and in the presence and absence of ART.

Secondary Objectives: 1) To compare LNG IUD safety to the safety of the C-IUD with respect to HIV progression as measured by changes in plasma viral load (VL) at 6 months between the two pre-ART study arms. 2) To explore LNG IUD safety with respect to non-HIV related outcomes, including hemoglobin change, incidence of sexually-transmitted infections (STIs) and pelvic inflammatory disease (PID). 3) To measure LNG IUD acceptability through device continuation and other measures for the LNG IUD as compared to the C-IUD. 4) To compare three genital tract sampling methods to determine which provides optimal recovery of HIV RNA and immune mediators over a series of three visits.

Primary Endpoints: Change in detection and quantity of HIV RNA genital VL measures between study arms at baseline and 6 months, and over 24 months following IUD insertion.

Secondary Endpoints: 1) Measures of HIV disease progression, including CD4 change, time to ART initiation, and mean plasma VL change from baseline to 6 and through 24 months among pre-ART women. 2) Hemoglobin change and incidence of STIs and PID for all participants through 24 months. 3) IUD continuation and expulsion rates between study arms comparing different IUDs over a 24-month period and acceptability measures through quantitative and qualitative methods. 4) Comparison of female genital tract sampling methods for recovery of HIV RNA as measured by VL and immune mediators (e.g. cytokines).

Study Site: Gugulethu Community Health Centre (GCHC), Cape Town, South Africa

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
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.
  • 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-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 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.
  • Intending residence in Cape Town area for next 30 months
  • No documented or known history of infertility or sterilization
  • No gross evidence of cervical neoplasia on examination
  • No prior history of ectopic pregnancy
  • No history of or suspected hormonally-dependent neoplasm or undiagnosed abnormal vaginal bleeding
  • Local language fluency and comprehension
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Catherine Todd, MD, MPH 1-919-544-7040 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
City University of New York, School of Public Health
Investigators
Principal Investigator: B Landon Myer, MBChB, PhD University of Cape Town
Principal Investigator: Catherine Todd, MD, MPH FHI 360
  More Information

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01721798     History of Changes
Other Study ID Numbers: 10369 
Study First Received: October 18, 2012
Last Updated: August 18, 2016
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:
AIDS acquired immunodeficiency syndrome
AE adverse event
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
Contraceptive Agents, Female
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Levonorgestrel
Copper
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 29, 2016