Antiretroviral Therapy for Acute and Chronic HIV Infection

Acute HIV Infection Clinical Trial

— AAHIV  

Official title:

Antiretroviral Therapy for Acute and Chronic HIV Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00796263
• Other study ID #: HAART for Acute HIV infection
• Status: Recruiting
• Phase: Phase 3
• Start date: April 2009
• Est. completion date: June 2033

Study information

• Verified date: June 2023
• Source: South East Asia Research Collaboration with Hawaii
• Contact: Nitiya Chomchey, RN, PhD
• Phone: 66 82 899 4433
• Email: nitiya.c[@]searchthailand.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 722
• Est. completion date: June 2033
• Est. primary completion date: June 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Acute HIV Infection
• Chronic HIV Infection
• Communicable Diseases
• HIV Infections
• Infections

Intervention

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

Locations

Country	Name	City	State
Thailand	Institute of HIV Research and Innovation	Bangkok

Sponsors (6)

Lead Sponsor	Collaborator
South East Asia Research Collaboration with Hawaii	Gilead Sciences, Merck Sharp & Dohme LLC, Pfizer, Thai Red Cross AIDS Research Centre, ViiV Healthcare

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV-1 plasma viral RNA measurements and CD4 counts during follow-up and after therapy		10 years
Secondary	Number of HIV and non-HIV related clinical events		10 years
Secondary	Adverse events related to HAART		10 years
Secondary	Adherence to HAART		10 years
Secondary	Resistance to antiretroviral medications		10 years