Principal Investigator - Dr. Chelsea Morroni, MD, MPH, PhD
Name of the Study: The Contraceptives and Dolutegravir-based ART (CODA) Study
Study Status: Recruiting
- 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.
- 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.
- To compare the trough plasma concentrations of DTG before and after contraceptive use to understand how LNG and DMPA may affect DTG exposure.
- To determine if the LNG implant and DMPA injectable inhibit ovulation in the presence of DTG.
- 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