Antiretroviral Therapy for Acute HIV Infection (AAHIV)
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ClinicalTrials.gov Identifier: NCT00796263 |
Recruitment Status
:
Recruiting
First Posted
: November 24, 2008
Last Update Posted
: April 19, 2018
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Acute HIV Infection | Drug: HAART Drug: Mega-HAART | Phase 3 |
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
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 536 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Antiretroviral Therapy for Acute HIV Infection |
Study Start Date : | April 2009 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | July 2021 |

Arm | Intervention/treatment |
---|---|
HAART
The proposed HAART regimen consists of:
|
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:
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Active Comparator: Mega-HAART
The proposed mega-HAART regimen consists of:
|
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:
|
- HIV-1 plasma viral RNA measurements and CD4 counts during follow-up and after therapy [ Time Frame: 10 years ]
- Number of HIV and non-HIV related clinical events [ Time Frame: 10 years ]
- Adverse events related to HAART [ Time Frame: 10 years ]
- Adherence to HAART [ Time Frame: 10 years ]
- Resistance to antiretroviral medications [ Time Frame: 10 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00796263
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 | |
Thai Red Cross AIDS Research Centre | Recruiting |
Bangkok, Thailand, 10330 | |
Contact: Duanghathai Suttichom, BNS 66 2 254 2566 ext 109 duanghathai.s@searchthailand.org |
Principal Investigator: | Praphan Phanuphak, M.D., Ph.D. | Thai Red Cross AIDS Research Centre |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Prof.Praphan Phanuphak, MD, PhD, Director, the Thai Red Cross AIDS Research Centre, South East Asia Research Collaboration with Hawaii |
ClinicalTrials.gov Identifier: | NCT00796263 History of Changes |
Other Study ID Numbers: |
HAART for Acute HIV infection |
First Posted: | November 24, 2008 Key Record Dates |
Last Update Posted: | April 19, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Prof.Praphan Phanuphak, MD, PhD, 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 Dolutegravir Reverse Transcriptase Inhibitors HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors |