Antiretroviral Therapy for Acute HIV Infection (AAHIV)
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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 |
- HIV-1 plasma viral RNA measurements and CD4 counts during follow-up and after therapy [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
- 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:
|
Drug: HAART
Tenofovir/emtricitabine (TDF/FTC) fixed dose combination 300/200 mg orally once daily Efavirenz (EFV) 600 mg orally once daily Other Names:
|
|
Active Comparator: Mega-HAART
The proposed mega-HAART regimen consists of:
|
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:
|
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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
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 HIV Infections 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 March 03, 2015