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Antiretroviral Therapy for Acute and Chronic HIV Infection (AAHIV)

Primary Purpose

Acute HIV Infection, Chronic HIV Infection

Status

Recruiting

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

HAART

About this trial

This is an interventional treatment trial for Acute HIV Infection focused on measuring Acute HIV infection, Chronic HIV infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years old
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)
Choose to start HAART according to protocol
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.
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.

Sites / Locations

Institute of HIV Research and InnovationRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HAART

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of HIV and non-HIV related clinical events

Adverse events related to HAART

Adherence to HAART

Resistance to antiretroviral medications

Full Information

NCT ID

NCT00796263

First Posted

November 21, 2008

Last Updated

June 21, 2023

Sponsor

SEARCH Research Foundation

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00796263

Brief Title

Antiretroviral Therapy for Acute and Chronic HIV Infection

Acronym

AAHIV

Official Title

Antiretroviral Therapy for Acute and Chronic HIV Infection

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 2009 (undefined)

Primary Completion Date

June 2033 (Anticipated)

Study Completion Date

June 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

SEARCH Research Foundation

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute HIV Infection, Chronic HIV Infection

Keywords

Acute HIV infection, Chronic HIV infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

722 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HAART

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

HAART

Other Intervention Name(s)

Kivexa, Tivicay

Intervention Description

2 nuceloside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications or Kivexa (ABC300/3TC300) orally once daily Dolutegravir(DTG) 50 mg orally once daily

Primary Outcome Measure Information:

Title

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

Time Frame

10 years

Secondary Outcome Measure Information:

Title

Number of HIV and non-HIV related clinical events

Time Frame

10 years

Title

Adverse events related to HAART

Time Frame

10 years

Title

Adherence to HAART

Time Frame

10 years

Title

Resistance to antiretroviral medications

Time Frame

10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years old 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) Choose to start HAART according to protocol 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nitiya Chomchey, RN, PhD

Phone

66 82 899 4433

nitiya.c@searchthailand.org

First Name & Middle Initial & Last Name or Official Title & Degree

Tassanee Luekasemsuk, MSc

tassanee.l@searchthailand.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Somchai Sriplienchan, MD, MPH

Organizational Affiliation

SEARCH Research Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of HIV Research and Innovation

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nitiya Chomchey, RN, PhD

Phone

66828994433

nitiya.c@searchthailand.org

First Name & Middle Initial & Last Name & Degree

Tassanee Luekasemsuk, MSc

tassanee.l@searchthailand.org

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28691436

Citation

Ananworanich J, Eller LA, Pinyakorn S, Kroon E, Sriplenchan S, Fletcher JL, Suttichom D, Bryant C, Trichavaroj R, Dawson P, Michael N, Phanuphak N, Robb ML. Viral kinetics in untreated versus treated acute HIV infection in prospective cohort studies in Thailand. J Int AIDS Soc. 2017 Jun 26;20(1):21652. doi: 10.7448/IAS.20.1.21652.

Results Reference

derived

PubMed Identifier

27317797

Citation

de Souza MS, Pinyakorn S, Akapirat S, Pattanachaiwit S, Fletcher JL, Chomchey N, Kroon ED, Ubolyam S, Michael NL, Robb ML, Phanuphak P, Kim JH, Phanuphak N, Ananworanich J; RV254/SEARCH010 Study Group. Initiation of Antiretroviral Therapy During Acute HIV-1 Infection Leads to a High Rate of Nonreactive HIV Serology. Clin Infect Dis. 2016 Aug 15;63(4):555-61. doi: 10.1093/cid/ciw365. Epub 2016 Jun 17.

Results Reference

derived

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Antiretroviral Therapy for Acute and Chronic HIV Infection

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