Name of the Study: The Contraceptives and Dolutegravir-based ART (CODA) Study

Study Status: Recruiting 

Study Objectives:

  1. To compare plasma LNG concentrations among (a) levonorgestrel contraceptive implant-users in Botswana receiving DTG-based ART and (b) HIV-negative, ART naïve levonorgestrel contraceptive implant users.
  2. To compare plasma medroxyprogesterone acetate (MPA) concentrations among (a) DMPA injectable-users in Botswana receiving DTG-based ART and (b) HIV-negative, ART naïve DMPA injectable users.
  3. To compare the trough plasma concentrations of DTG before and after contraceptive use to understand how LNG and DMPA may affect DTG exposure.
  4. To determine if the LNG implant and DMPA injectable inhibit ovulation in the presence of DTG.
  5. To evaluate safety, tolerability, bleeding patterns and contraceptive method continuation with concomitant LNG implant or DMPA injectable, compared to controls (HIV negative, ART naïve women). 

Study Design: Phase IV, open label, non-randomized, parallel-arm, pharmacokinetic study

Study Population: Women of childbearing age in Botswana (either living with HIV and using DTG-based ART or without HIV infection and ART naïve) who have already chosen to use the LNG subdermal implant or the DMPA injectable for contraceptive protection.

Study Size: 140 participants (70 women initiating the LNG implant and 70 women initiating the DMPA injectable) 

Study Duration: 2 years 

Sponsor: ViiV Healthcare