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History of Changes for Study: NCT00796263
Antiretroviral Therapy for Acute HIV Infection (AAHIV)
Latest version (submitted October 19, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 21, 2008 None (earliest Version on record)
2 November 24, 2008 Contacts/Locations and Study Status
3 July 28, 2009 Recruitment Status, Study Status and Contacts/Locations
4 May 2, 2011 Arms and Interventions, Outcome Measures, Study Status, Study Design, Study Description and Oversight
5 July 21, 2011 Study Design and Study Status
6 April 4, 2014 Sponsor/Collaborators, Study Status, Outcome Measures and Study Design
7 November 17, 2014 Arms and Interventions and Study Status
8 May 27, 2015 Study Status
9 March 6, 2016 Study Status and IPDSharing
10 December 7, 2016 Study Status
11 January 25, 2017 Arms and Interventions, Outcome Measures, Study Status, Study Design and Sponsor/Collaborators
12 April 17, 2018 Study Status, Sponsor/Collaborators and Study Design
13 June 26, 2018 Study Design, Arms and Interventions, Conditions, Study Status and Study Identification
14 September 19, 2019 Study Status and Study Design
15 June 29, 2020 Study Status and Study Design
16 September 21, 2021 Study Status
17 October 19, 2022 Study Status
Comparison Format:

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Study NCT00796263
Submitted Date:  April 17, 2018 (v12)

Open or close this module Study Identification
Unique Protocol ID: HAART for Acute HIV infection
Brief Title: Antiretroviral Therapy for Acute HIV Infection (AAHIV)
Official Title: Antiretroviral Therapy for Acute HIV Infection
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2018
Overall Status: Recruiting
Study Start: April 2009
Primary Completion: April 2021 [Anticipated]
Study Completion: July 2021 [Anticipated]
First Submitted: November 21, 2008
First Submitted that
Met QC Criteria:
November 21, 2008
First Posted: November 24, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 17, 2018
Last Update Posted: April 19, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: South East Asia Research Collaboration with Hawaii
Responsible Party: Principal Investigator
Investigator: Prof.Praphan Phanuphak, MD, PhD
Official Title: Director, the Thai Red Cross AIDS Research Centre
Affiliation: South East Asia Research Collaboration with Hawaii
Collaborators: Thai Red Cross AIDS Research Centre
Pfizer
Gilead Sciences
Merck Sharp & Dohme LLC
ViiV Healthcare
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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

Open or close this module Conditions
Conditions: Acute HIV Infection
Keywords: Acute HIV infection
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 536 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.

Open or close this module Contacts/Locations
Central Contact Person: Praphan Phanuphak, M.D., Ph.D
Telephone: 66 2 253 0996
Email: praphan.p@chula.ac.th
Central Contact Backup: Duanghathai Suttichom, BNS
Telephone: 66 2 254 2566 Ext. 109
Email: duanghathai.s@searchthailand.org
Study Officials: Praphan Phanuphak, M.D., Ph.D.
Principal Investigator
Thai Red Cross AIDS Research Centre
Locations: Thailand
Thai Red Cross AIDS Research Centre
[Recruiting]
Bangkok, Thailand, 10330
Contact:Contact: Duanghathai Suttichom, BNS 66 2 254 2566 Ext. 109 duanghathai.s@searchthailand.org
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Links:
Available IPD/Information:

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