Clinical Trials

MainTitle

Antiretroviral Therapy for Acute HIV Infection (AAHIV)

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2017 by Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii

Sponsor
South East Asia Research Collaboration with Hawaii

Collaborator
Thai Red Cross AIDS Research Centre
Pfizer
Gilead Sciences
Merck Sharp & Dohme Corp.
ViiV Healthcare

Information provided by (Responsible Party)
Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii

ClinicalTrials.gov Identifier
NCT00796263

First received: November 21, 2008
Last updated: January 25, 2017
Last Verified: January 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Acute HIV Infection

Drug : HAART
Drug : Mega-HAART
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antiretroviral Therapy for Acute HIV Infection

Further study details as provided by Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii:

Primary Outcome Measures

  • HIV-1 plasma viral RNA measurements and CD4 counts during follow-up and after therapy [ Time Frame: 10 years ]
Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: April 2009
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: HAART
The proposed HAART regimen consists of: 2 nuceloside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications Dolutegravir(DTG) 50 mg orally once daily
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 Name:
  • Kivexa
  • Tivicay

Active Comparator: Mega-HAART
The proposed mega-HAART regimen consists of: 2 nuceloside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications Dolutegravir(DTG) 50 mg orally once daily Maraviroc (MVC)300 mg orally twice daily (for a period not exceeding the first24 months)
Drug: Mega-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
  • Maraviroc (MVC) 600 mg orally twice daily

Other Name:
  • Kivexa
  • Tivicay
  • Celsentri

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796263

Contacts

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

Locations

Thailand
Thai Red Cross AIDS Research Centre Recruiting
Bangkok, Thailand, 10330
Contact: Duanghathai Suttichom, BNS    66 2 254 2566 ext 109    duanghathai.s@searchthailand.org

Sponsors and Collaborators

South East Asia Research Collaboration with Hawaii
Thai Red Cross AIDS Research Centre
Pfizer
Gilead Sciences
Merck Sharp & Dohme Corp.
ViiV Healthcare

Investigators

Principal Investigator: Praphan Phanuphak, M.D., Ph.D. Thai Red Cross AIDS Research Centre
More Information

More Information


Responsible Party: Assoc.Prof.Jintanat Ananworanich, M.D., Assoc. Prof., South East Asia Research Collaboration with Hawaii  
ClinicalTrials.gov Identifier: NCT00796263   History of Changes  
Other Study ID Numbers: HAART for Acute HIV infection  
Study First Received: November 21, 2008  
Last Updated: January 25, 2017  
Individual Participant Data    
Plan to Share IPD: Undecided  

Keywords provided by Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii:

Acute HIV infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Dolutegravir
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.