Comparison of Two IUDs Among Cape Town HIV-positive Women - Full Text View

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Levonorgestrel

U.S. FDA Resources

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:


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 Levonorgestrel	Copper Contraceptive Agents, Female 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 September 23, 2016