Antiretroviral Therapy for Acute and Chronic HIV Infection

• Status: Recruiting
• Trial end date: 2033-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a protocol designed to randomize subjects with acute HIV infection to receive standard HAART or mega-HAART for subject who are enrolled in SEARCH 010 study (protocol title: Establish and characterize an acute HIV infection cohort in a Thai high risk population.

To describe the impact of standard HAART versus mega-HAART initiated during the acute HIV infection period on immunological and virological outcomes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: South East Asia Research Collaboration with Hawaii
• Collaborators: Gilead Sciences; Merck Sharp & Dohme Corp.; Pfizer; Thai Red Cross AIDS Research Centre; ViiV Healthcare
• Treatments: Dolutegravir; Efavirenz; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

1. Age ≥ 18 years old

2. Enrolled in SEARCH 010 protocol and have protocol-defined acute HIV-1 infection (Tested 4th generation HIV EIA negative and NAT positive or tested 4th generation HIV EIA positive, negative by less sensitive EIA and NAT positive)

3. Choose to start HAART according to protocol

4. Understand the study and sign informed consent form. Persons who cannot read will have the consent form read to them by a study staff and they can give informed consent by using thumb print.

5. Availability for follow-up for the planned study duration

Exclusion Criteria:

1. Persons who have a history of a medical or psychiatric disorder by investigator's interview and physical examination according to standard practices, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.