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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00796263
Other study ID # HAART for Acute HIV infection
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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