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Antiretroviral Therapy for Acute HIV Infection (AAHIV)

This study is currently recruiting participants.
Verified April 2011 by South East Asia Research Collaboration with Hawaii
Sponsor:
Collaborators:
Thai Red Cross AIDS Research Centre
Pfizer
Gilead Sciences
Merck
Information provided by:
South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier:
NCT00796263
First received: November 21, 2008
Last updated: July 21, 2011
Last verified: April 2011
History of Changes
  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: Anti-HIV Agents
 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:

U.S. FDA Resources

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: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of HIV and non-HIV related clinical events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Adverse events related to HAART [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Adherence to HAART [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Resistance to antiretroviral medications [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
Study Start Date: April 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HAART Drug: Anti-HIV Agents

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

Efavirenz (EFV) 600 mg orally once daily
Active Comparator: Mega-HAART Drug: Anti-HIV Agents

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

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

No publications provided

Responsible Party: Ms.Duanghathai Suttichom, SEARCH
ClinicalTrials.gov Identifier: NCT00796263     History of Changes
Other Study ID Numbers: HAART for Acute HIV infection
Study First Received: November 21, 2008
Last Updated: July 21, 2011
Health Authority: Thailand: Ethical Committee

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

Additional relevant MeSH terms:
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
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013