Antiretroviral Therapy for Acute and Chronic HIV Infection (AAHIV)

SEARCH Research Foundation

Status and phase: Enrolling; Phase 3

Conditions: Acute HIV Infection; Chronic HIV Infection

Treatments: Drug: HAART

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00796263

HAART for Acute HIV infection

Details and patient eligibility

About

The purpose for this protocol is to provide safe and effective standard ART to SEARCH 010 and SEARCH 013 participants. Participants are enrolled in an acute HIV infection study (SEARCH 010 protocol: 'Establish and characterize an acute HIV infection cohort in a Thai high-risk population') or in a study of chronic HIV infection (SEARCH 013 protocol 'Characteristics of immunity in gut mucosa, spinal fluid, lymph node and blood of HIV negative and HIV positive Thais').

Full description

To compare systemic and tissue compartments (genital secretion, CNS, gut and lymph node) outcomes among individuals who initiate HIV treatment during acute vs. chronic HIV infection. The outcomes will be compared by stages of infection and antiretroviral regimens. Participants are enrolled in an acute HIV infection study (SEARCH 010 protocol: 'Establish and characterize an acute HIV infection cohort in a Thai high-risk population') or in a study of chronic HIV infection (SEARCH 013 protocol 'Characteristics of immunity in gut mucosa, spinal fluid, lymph node and blood of HIV negative and HIV positive Thais') with the latter serving as controls for the acutely infected individuals.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old
2. Enrolled in the SEARCH 010 or 013 protocols with documentation of acute or chronic protocol defined HIV-1 infection and chooses to initiate or continue ART
3. Understand the study and sign informed consent form. Persons who cannot read will have the consent form read and explained to them by a member of the study staff and they can give informed consent by using their thumb print
4. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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900 participants in 1 patient group

HAART

Other group

Description:

The proposed HAART regimen consists of: * 1 or 2 nucleoside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications plus * Dolutegravir(DTG) 50 mg orally once daily

Treatment:

Drug: HAART