Comparison of Two IUDs Among Cape Town HIV-positive Women
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ClinicalTrials.gov Identifier: NCT01721798 |
Recruitment Status :
Completed
First Posted : November 6, 2012
Last Update Posted : August 21, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Device: Mirena levonorgestrel IUD Device: Copper T-380a IUD | Not Applicable |
Design: Single site, double-blind, randomized controlled trial
Population: HIV-positive South African women between the ages of 18 and 40 years
Study size: At least 166 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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 205 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Actual Study Start Date : | November 10, 2013 |
Actual Primary Completion Date : | July 13, 2018 |
Actual Study Completion Date : | July 13, 2018 |

Arm | Intervention/treatment |
---|---|
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 |
- 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 ]
- 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 ]
- 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 ]
- Measure LNG IUD acceptability through device continuation and other measures for the LNG IUD as compared to the C-IUD. [ Time Frame: 24 months ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721798
South Africa | |
University of Cape Town | |
Cape Town, Western Cape Province, South Africa, 7701 |
Principal Investigator: | B Landon Myer, MBChB, PhD | University of Cape Town | |
Principal Investigator: | Catherine Todd, MD, MPH | FHI 360 |
Responsible Party: | FHI 360 |
ClinicalTrials.gov Identifier: | NCT01721798 |
Other Study ID Numbers: |
10369 |
First Posted: | November 6, 2012 Key Record Dates |
Last Update Posted: | August 21, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
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 Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptives, Oral, Synthetic Contraceptives, Oral Trace Elements Micronutrients Nutrients Growth Substances |