Antiretroviral Therapy for Acute and Chronic HIV Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-13

Study Completion Date

2033-06-30

Brief Summary

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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').

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Detailed Description

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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.

Conditions

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Acute HIV Infection Chronic HIV Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HAART

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

Group Type OTHER

HAART

Intervention Type DRUG

1 (lamivudine) or 2 (lamivudine + abacavir) nuceloside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications once daily

plus

dolutegravir(DTG) 50 mg orally once daily

Interventions

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HAART

1 (lamivudine) or 2 (lamivudine + abacavir) nuceloside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications once daily

plus

dolutegravir(DTG) 50 mg orally once daily

Intervention Type DRUG

Other Intervention Names

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Triumeq Dovato

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No