Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Antiretroviral Therapy for Acute HIV Infection (AAHIV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by South East Asia Research Collaboration with Hawaii
Sponsor:
Collaborators:
Thai Red Cross AIDS Research Centre
Pfizer
Gilead Sciences
Merck Sharp & Dohme Corp.
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: November 17, 2014
Last verified: November 2014

November 21, 2008
November 17, 2014
April 2009
April 2019   (final data collection date for primary outcome measure)
HIV-1 plasma viral RNA measurements and CD4 counts during follow-up and after therapy [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
HIV-1 plasma viral RNA measurements and CD4 counts during follow-up and after therapy [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00796263 on ClinicalTrials.gov Archive Site
  • Number of HIV and non-HIV related clinical events [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • Adverse events related to HAART [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • Adherence to HAART [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • Resistance to antiretroviral medications [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Antiretroviral Therapy for Acute HIV Infection
Antiretroviral Therapy for Acute HIV Infection

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute HIV Infection
  • Drug: HAART

    Tenofovir/emtricitabine (TDF/FTC) fixed dose combination 300/200 mg orally once daily

    Efavirenz (EFV) 600 mg orally once daily

    Other Names:
    • Truvada
    • Stocrin
  • Drug: Mega-HAART

    Tenofovir/emtricitabine (TDF/FTC) fixed dose combination 300/200 mg orally once daily

    Efavirenz (EFV) 600 mg orally once daily

    Maraviroc (MVC) 600 mg orally twice daily

    Raltegravir (RAL) 400 mg orally twice daily

    Other Names:
    • Truvada
    • Isentress
    • Celsentri
    • Stocrin
  • HAART

    The proposed standard HAART regimen consists of:

    • Tenofovir (TDF) 300 mg orally once daily
    • Emtricitabine (FTC) 200 mg or Lamivudine (3TC) 300 mg orally once daily
    • Efavirenz (EFV) 600 mg orally once daily
    Intervention: Drug: HAART
  • Active Comparator: Mega-HAART

    The proposed mega-HAART regimen consists of:

    • Tenofovir (TDF) 300 mg orally once daily
    • Emtricitabine (FTC) 200 mg orally once daily
    • Efavirenz (EFV) 600 mg orally once daily
    • Maraviroc (MVC) 600 mg orally twice daily (only for the first 6 months)
    • Raltegravir (RAL) 400 mg orally twice daily (only for the first 6 months)
    Intervention: Drug: Mega-HAART
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
July 2019
April 2019   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
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
Thailand
 
NCT00796263
HAART for Acute HIV infection
No
Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii
South East Asia Research Collaboration with Hawaii
  • Thai Red Cross AIDS Research Centre
  • Pfizer
  • Gilead Sciences
  • Merck Sharp & Dohme Corp.
Principal Investigator: Praphan Phanuphak, M.D., Ph.D. Thai Red Cross AIDS Research Centre
South East Asia Research Collaboration with Hawaii
November 2014

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