Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00796263
Previous Study | Return to List | Next Study

Antiretroviral Therapy for Acute and Chronic HIV Infection (AAHIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00796263
Recruitment Status : Recruiting
First Posted : November 24, 2008
Last Update Posted : June 30, 2020
Sponsor:
Collaborators:
Thai Red Cross AIDS Research Centre
Pfizer
Gilead Sciences
Merck Sharp & Dohme Corp.
ViiV Healthcare
Information provided by (Responsible Party):
Prof.Praphan Phanuphak, MD, PhD, South East Asia Research Collaboration with Hawaii

Tracking Information
First Submitted Date  ICMJE November 21, 2008
First Posted Date  ICMJE November 24, 2008
Last Update Posted Date June 30, 2020
Study Start Date  ICMJE April 2009
Estimated Primary Completion Date June 2033   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
HIV-1 plasma viral RNA measurements and CD4 counts during follow-up and after therapy [ Time Frame: 10 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2008)
HIV-1 plasma viral RNA measurements and CD4 counts during follow-up and after therapy [ Time Frame: 2.5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Number of HIV and non-HIV related clinical events [ Time Frame: 10 years ]
  • Adverse events related to HAART [ Time Frame: 10 years ]
  • Adherence to HAART [ Time Frame: 10 years ]
  • Resistance to antiretroviral medications [ Time Frame: 10 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2008)
Number of HIV and non-HIV related clinical events Adverse events related to HAART Adherence to HAART Resistance to antiretroviral medications [ Time Frame: 2.5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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.D 66 2 253 0996 praphan.p@chula.ac.th
Contact: Duanghathai Suttichom, BNS 66 2 254 2566 ext 109 duanghathai.s@searchthailand.org
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