Protocol Number: FH-94
Study Objetives:
Primary:
* To evaluate the virological response to Dolutegravir/Lamivudine in naive pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates.
Secondary:
* To evaluate the incidence of maternal adverse events.
* To evaluate perinatal outcomes at delivery.
* To evaluate maximum virological suppression at delivery.
* To evaluate the incidence of changes in body weight exceeding what is expected for gestation.
* To evaluate the immune response based on changes in CD4, CD8, and CD4/CD8 ratio values during pregnancy.
* Assess baseline resistance and the development of resistance to virological failure to integrase inhibitors and INTRs during treatment with DTG+3TC or DTG+TDF/XTC or DTG+TAF/FTC.
* To evaluate the incidence of HIV infection in children that breastfeed.
* To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC.
Exploratory:
* To explore the non-inferiority of DTG+3TC therapy compared to DTG+TDF/XTC or DTG+TAF/FTC treatment.
* To evaluate the frequency of antiretroviral therapy withdrawal or modification before delivery.