Antiretroviral Therapy for Acute HIV Infection (AAHIV)

This study is currently recruiting participants. (see Contacts and Locations)

Verified March 2016 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: March 6, 2016

Last verified: March 2016

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: 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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Emtricitabine Tenofovir Efavirenz

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: 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 2021
Estimated Primary Completion Date:	April 2021 (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 (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥ 18 years old
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)
Choose to start HAART according to protocol
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.
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


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:	March 6, 2016
Health Authority:	Thailand: Ethical Committee
Individual Participant Data
Plan to Share IPD:	Undecided

Keywords provided by 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 Tenofovir Efavirenz	Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers

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
Tenofovir
Efavirenz

Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers

ClinicalTrials.gov processed this record on September 29, 2016

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