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Antiretroviral Therapy for Acute HIV Infection (AAHIV)

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ClinicalTrials.gov Identifier: NCT00796263
Recruitment Status : Recruiting
First Posted : November 24, 2008
Last Update Posted : April 19, 2018
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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Acute HIV Infection Drug: HAART Drug: Mega-HAART Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 536 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antiretroviral Therapy for Acute HIV Infection
Study Start Date : April 2009
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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 Names:
  • 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 Names:
  • Kivexa
  • Tivicay
  • Celsentri


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Secondary Outcome Measures :
  1. Number of HIV and non-HIV related clinical events [ Time Frame: 10 years ]
  2. Adverse events related to HAART [ Time Frame: 10 years ]
  3. Adherence to HAART [ Time Frame: 10 years ]
  4. Resistance to antiretroviral medications [ Time Frame: 10 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof.Praphan Phanuphak, MD, PhD, Director, the Thai Red Cross AIDS Research Centre, South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier: NCT00796263     History of Changes
Other Study ID Numbers: HAART for Acute HIV infection
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Prof.Praphan Phanuphak, MD, PhD, South East Asia Research Collaboration with Hawaii:
Acute HIV infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Slow Virus Diseases
Dolutegravir
Reverse Transcriptase Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors