Antiretroviral Therapy for Acute and Chronic HIV Infection

NCT00796263

Last updated date
Study Location
Thai Red Cross AIDS Research Centre
Bangkok, , 10330, Thailand
Contact
66 2 253 0996

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute HIV Infection, Chronic HIV Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Acute HIV Infection, Chronic HIV InfectionAntiretroviral Therapy for Acute and Chronic HIV Infection
NCT00796263
  1. Bangkok,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Antiretroviral Therapy for Acute and Chronic HIV Infection
Official Title  ICMJE Antiretroviral Therapy for Acute and Chronic HIV Infection
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute HIV Infection
  • Chronic HIV Infection
Intervention  ICMJE 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
Study Arms  ICMJE HAART

The proposed HAART regimen consists of:

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2020)
644
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2008)
30
Estimated Study Completion Date  ICMJE June 2033
Estimated Primary Completion Date June 2033   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Praphan Phanuphak, M.D., Ph.D66 2 253 0996[email protected]
Contact: Duanghathai Suttichom, BNS66 2 254 2566 ext 109[email protected]
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00796263
Other Study ID Numbers  ICMJE HAART for Acute HIV infection
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
Responsible Party Prof.Praphan Phanuphak, MD, PhD, South East Asia Research Collaboration with Hawaii
Study Sponsor  ICMJE South East Asia Research Collaboration with Hawaii
Collaborators  ICMJE
  • Thai Red Cross AIDS Research Centre
  • Pfizer
  • Gilead Sciences
  • Merck Sharp & Dohme Corp.
  • ViiV Healthcare
Investigators  ICMJE
Principal Investigator:Praphan Phanuphak, M.D., Ph.D.Thai Red Cross AIDS Research Centre
PRS Account South East Asia Research Collaboration with Hawaii
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP