Viral and Host Factors in the Transmission and Pathogenesis of HIV

NCT00219947 | Terminated

• 1 other identifier: MMA-448
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

To study the collection of blood from individuals known to be at high risk for HIV-infection or who have been recently infected with HIV. The data collected are used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment Guidelines.

Conditions

HIV Infections

Keywords

HIV Infection; Acute HIV Infection; Primary HIV Infection; Acute Seroconversion Syndrome

Outcome Measures

Primary Outcomes (1)

• Participants are tested for HIV-1 RNA levels, the presence of antibodies to HIV antigens, and T cell subsets

  first visit

Secondary Outcomes (1)

• Data will be used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment

  first visit

Study Arms (2)

high risk

Blood draw from individuals known to be or at high risk for HIV-infection

Other: blood draw

diagnosed

Blood draw f rom individuals diagnosed with HIV infection

Other: blood draw

Interventions

blood draw OTHER

* T cell subset enumeration * Serologic reactivity with HIV antigens * Viral load assays by bDNA, PCR, or RT-PCR * Routine Laboratory assessments (chemistries, liver function tests, hepatitis serology, RPR) * HIV-1 Resistance Testing

diagnosed; high risk

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects are either referred by primary health care providers, self-referred, or may be seeking enrollment in other ADARC clinical trials in the NYC area.

You may qualify if:

• recently infected with HIV-1 HIV-1 negative, and at high risk for infection

You may not qualify if:

• none

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (2)

Aaron Diamond AIDS Research Center (ADARC)

New York, New York, 10016, United States

Location

Rockefeller University Hospital

New York, New York, 10021, United States

Location

Related Links

• The Aaron Diamond AIDS Research Center

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

HIV Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Martin M Markowitz, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: July 1, 2000
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)