Establish and Characterize an Acute HIV Infection Cohort in a High Risk Population

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by South East Asia Research Collaboration with Hawaii
Sponsor:
Collaborators:
Armed Forces Research Institute of Medical Sciences, Thailand
Thai Red Cross AIDS Research Centre
Information provided by (Responsible Party):
Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier:
NCT00796146
First received: November 21, 2008
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

To describe clinical, immunological, and virological characteristics of persons with acute HIV infection

  1. To describe demographics and behavioral risk factors for those identified with acute HIV infection
  2. To describe neurocognitive function and neuroimaging findings in acute HIV infection as well as describe immune response, HIV-1 genotypes and sequences in the cerebrospinal fluid.
  3. To describe the number and characteristics of sexual contacts
  4. To describe the willingness of acute HIV-infected subjects to allow the tracking of their sexual contacts for voluntary HIV counseling and testing (VCT)
  5. To describe immune response, HIV-1 genotypes and sequences in the genital compartment
  6. To describe T cell depletion in the gut mucosa in acute HIV infection and describe the changes in gut T cell during follow up
  7. To archive samples for future investigations including determination of viral evolution, and cell-mediated and humoral immune responses in peripheral blood and mucosal compartments

Condition
Acute HIV Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by South East Asia Research Collaboration with Hawaii:

Primary Outcome Measures:
  • Number of HIV and non-HIV related clinical events [ Time Frame: It will take approximately 72 months to complete the study. The screening and enrollment is 48 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • demographics and behavioral risk factors for those identified with acute HIV infection [ Time Frame: approximately 72 months to complete the study. The screening and enrollment is 48 months ] [ Designated as safety issue: Yes ]
  • neurocognitive function and neuroimaging findings in acute HIV infection as well as describe immune response, HIV-1 genotypes and sequences in the cerebrospinal fluid [ Time Frame: approximately 72 months to complete the study. The screening and enrollment is 48 months ] [ Designated as safety issue: Yes ]
  • number and characteristics of sexual contacts [ Time Frame: approximately 72 months to complete the study. The screening and enrollment is 48 months ] [ Designated as safety issue: Yes ]
  • the willingness of acute HIV-infected subjects to allow the tracking of their sexual contacts for voluntary HIV counseling and testing (VCT) [ Time Frame: approximately 72 months to complete the study. The screening and enrollment is 48 months ] [ Designated as safety issue: Yes ]
  • immune response, HIV-1 genotypes and sequences in the genital compartment [ Time Frame: approximately 72 months to complete the study. The screening and enrollment is 48 months ] [ Designated as safety issue: Yes ]
  • T cell depletion in the gut mucosa in acute HIV infection and describe the changes in gut T cells during follow up [ Time Frame: approximately 72 months to complete the study. The screening and enrollment is 48 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

serum, PBMC


Estimated Enrollment: 211
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)
Detailed Description:

This study will establish an acute infection cohort which is predominantly non-subtype B. Description of the early events in HIV infection is critical to HIV vaccine development and understanding HIV-1 immunopathogenesis. The ability to establish this cohort and identify individuals with acute HIV-1 infection would provide the basis for future hypothesis-driven proposals.

Subjects will be recruited at the TRCARC. Subjects seeking VCT will be asked to provide contact information. Blood samples, either plasma or whole blood collected on filter paper (dried blood spots, or DBS) will be screened for acute HIV infection by pooled or individual NAT if non-reactive after screening by an EIA capable of detecting both HIV antibody and antigen (4th generation or sensitive EIA). Additionally, 4th generation reactive samples will be screened with a non-IgM sensitive EIA capable of detecting HIV antibody only (less sensitive EIA) within 1-2 days of sample collection. Those who are found to have acute HIV infection will be asked to enroll in the cohort study. These acute HIV-infected participants will be followed prospectively at week 0, day 2, 3, 5, 7, 10 then weeks 2, 4, 8, 12, 16, 20, 24, then every 12 weeks until the end of the study (maximum of 192 weeks of follow up). Subjects will receive blood testing for CD4, HIV RNA, ALT, creatinine and lipids, and urinalysis. Subjects will be asked to complete a questionnaire on HIV risk behavior. Archiving of plasma and PBMC for future immunologic and virologic testing will be performed. Optional study procedures include 1) collection of genital secretions 2) collection of cerebrospinal fluid 3) brain MRI/MRS without gadolinium 4) sampling of gut-associated lymphoid tissue by colon biopsy 5) genetic testing 6) tracking of and offering VCT to sexual contacts of acute HIV-infected subjects. Subjects are encouraged to be hospitalized for the first 3-7 days for post-procedural observation and for ease of follow up.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The population seeking VCT at the TRCAC will be screened. They are comprised of both men and women of different ages, economic stratus and education level: a large portion of whom are at high risk for HIV infection through commercial sex work and MSM.

Criteria

Inclusion Criteria:

  1. Age >18 years old
  2. 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. 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.
  4. 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: NCT00796146

Contacts
Contact: Nittaya Phanuphak, MD. 662 254 2566 ext 101 Nittaya.p@trcarc.org
Contact: Nitiya Chomchey 662 254 2566 ext 102 Nitiya.c@searchthailand.org

Locations
Thailand
Thai Red Cross AIDS Research Centre Recruiting
Bangkok, Thailand, 10330
Contact: Nittaya Phanuphak, MD    66 2 253 0996    nittaya.p@trcarc.org   
Contact: Duanghathai Suttichom, BNS    662 254 2566 ext 109    duanghathai.s@searchthailand.org   
Principal Investigator: Nittaya Phanuphak, M.D., Ph.D         
Sponsors and Collaborators
South East Asia Research Collaboration with Hawaii
Armed Forces Research Institute of Medical Sciences, Thailand
Thai Red Cross AIDS Research Centre
Investigators
Study Chair: Jintanat Ananworanich, MD US Military HIV Research Program
  More Information

No publications provided

Responsible Party: Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier: NCT00796146     History of Changes
Other Study ID Numbers: SEARCH010/ RV 254
Study First Received: November 21, 2008
Last Updated: September 25, 2014
Health Authority: Thailand: Ethical Committee
United States: Federal Government

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Communicable Diseases
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014