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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antiretroviral Therapy for Acute HIV Infection

Resource links provided by NLM:


Further study details as provided by 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: 6 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: April 2009
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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)
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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.
Investigators
Principal Investigator: Praphan Phanuphak, M.D., Ph.D. Thai Red Cross AIDS Research Centre
  More Information

No publications provided

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: November 17, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by South East Asia Research Collaboration with Hawaii:
Acute HIV infection

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Emtricitabine
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014