Clinical Trial:

ARIA

Full Name

HIV-1/ A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve women (2_PRO00001231)

Description

Approximately 474 women will be enrolled on this research study. This study is comparing dolutegravir combined with abacavir and lamivudine (DTG/ABC/3TC) to atazanavir plus ritonavir and truvada (ATV+RTV+TDF/FTC fixed dose combination). About 237 women will take DTG/ABC/3TC, and about 237 women will take ATV+RTV+TDF/FTC fixed dose combination. Participants will be assigned by chance to one of the two treatment groups. Neither the participant nor their study doctor can choose the group. Participants have a 50% chance of being placed in either group. While the participant and the study doctor cannot choose the group, the participant and the study doctor will know to which group they were assigned. Those participants assigned to the DTG/ABC/3TC group will take one pill once a day. Those assigned to the ATV+RTV+TDF/FTC fixed dose combination group will three pills once a day. After 48 weeks, the study will end. Those in the DTG/ABC/3TC group may choose to stay on the drug and come in for visits every 12 weeks until the drug becomes available or the drug no longer works. Those on the ATV+RTV+TDF/FTC fixed dose combination will no longer receive their HIV drugs as part of the study once it is over. New arrangements for HIV drugs will need to be made. Participants who had a liver safety event that the study doctor felt was not caused by the study drug will have the opportunity to consent to take the study drug again (restart). Participants who had a liver safety event that was deemed to be possibly related will have the opportunity to consent to take the study drug again (rechallenge).

Eligibility

Inclusion Criteria
  • Must be greater than or equal to 18 years of age
  • Must have HIV-1 infection as documented by Screening plasma HIV-1 RNA greater than or equal to 500 c/mL
  • Must not have any degree of hepatic impairment
  • Must not be pregnant or breastfeeding
  • Must not have had treatment with an HIV immunotherapeutic vaccine within 90 days of screening
Doctor(s) Running This Study

Specialties

  • Infectious Diseases
  • Internal Medicine

Area of focus i

  • Hepatitis Care
  • HIV Care
  • HIV Pre-exposure Prophylaxis (PrEP)
  • LGBTQ+ Patient Support
  • Transgender health

LVPG Cliniciani

Accepting New Patients