Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women
Condition: HIV
MeSH terms: HIV Seropositivity
Study type: Interventional

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.
    

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: 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 antiretroviral therapy (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 ribonucleic acid (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
    

Intervention name(s): Mirena levonorgestrel IUD; Copper T-380a IUD
Intervention type(s): Device; Device
Intervention description(s): Intrauterine contraception system; intrauterine contraception system
Intervention MeSH terms: Copper; Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
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