Antiretroviral Therapy for Acute and Chronic HIV Infection (AAHIV)

June 21, 2023 updated by: Prof.Praphan Phanuphak, MD, PhD, South East Asia Research Collaboration with Hawaii

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

722

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: HAART

The proposed HAART regimen consists of:

  • 2 nuceloside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications
  • Dolutegravir(DTG) 50 mg orally once daily
Drug: HAART

2 nuceloside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications or Kivexa (ABC300/3TC300) orally once daily

Dolutegravir(DTG) 50 mg orally once daily

Other Names:
  • Kivexa
  • Tivicay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV-1 plasma viral RNA measurements and CD4 counts during follow-up and after therapy
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of HIV and non-HIV related clinical events
Time Frame: 10 years
10 years
Adverse events related to HAART
Time Frame: 10 years
10 years
Adherence to HAART
Time Frame: 10 years
10 years
Resistance to antiretroviral medications
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South East Asia Research Collaboration with Hawaii

Collaborators

Merck Sharp & Dohme LLC
Pfizer
Gilead Sciences
Thai Red Cross AIDS Research Centre
ViiV Healthcare

Investigators

  • Principal Investigator: Somchai Sriplienchan, MD, MPH, SEARCH Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Estimated)

June 1, 2033

Study Completion (Estimated)

June 1, 2033

Study Registration Dates

First Submitted

November 21, 2008

First Submitted That Met QC Criteria

November 21, 2008

First Posted (Estimated)

November 24, 2008

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAART for Acute HIV infection

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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