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Antiretroviral Therapy for Acute and Chronic HIV Infection

Antiretroviral Therapy for Acute and Chronic HIV Infection

Recruiting
18 years and older
All
Phase 3

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Overview

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.

Description

HIV-1 plasma viral RNA measurements and CD4 counts during follow-up and after therapy

Number of HIV and non-HIV related clinical events Adverse events related to HAART Adherence to HAART Resistance to antiretroviral medications

Eligibility

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.

Study details
    Acute HIV Infection
    Chronic HIV Infection

NCT00796263

SEARCH Research Foundation

27 January 2024

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