Viral and Host Factors in the Transmission and Pathogenesis of HIV
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ClinicalTrials.gov Identifier: NCT00219947 |
Recruitment Status
:
Recruiting
First Posted
: September 22, 2005
Last Update Posted
: January 11, 2018
|
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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.
Condition or disease | Intervention/treatment |
---|---|
HIV Infections | Other: blood draw |
This phlebotomy protocol permits the collection of blood from individuals known to be at high risk for HIV-infection or who have been recently infected with HIV.
Participants will have from 10 to 60 ml (approximately 1 to 4 tablespoons) of blood drawn for one or all of the following tests:
- 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
These data are used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment Guidelines
Study Type : | Observational |
Estimated Enrollment : | 600 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Viral and Host Factors in the Transmission and Pathogenesis of HIV |
Study Start Date : | July 2000 |
Estimated Primary Completion Date : | July 2019 |
Estimated Study Completion Date : | July 2019 |

Group/Cohort | Intervention/treatment |
---|---|
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
|
- Participants are tested for HIV-1 RNA levels, the presence of antibodies to HIV antigens, and T cell subsets [ Time Frame: first visit ]
- Data will be used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment [ Time Frame: first visit ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
recently infected with HIV-1 HIV-1 negative, and at high risk for infection
Exclusion Criteria:

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): NCT00219947
Contact: Melissa La Mar | 212-327-7280 | mlamar@rockefeller.edu |
United States, New York | |
Aaron Diamond AIDS Research Center (ADARC) | Recruiting |
New York, New York, United States, 10016 | |
Contact: Melissa La Mar 212-327-7280 mlamar@adarc.org | |
Rockefeller University Hospital | Recruiting |
New York, New York, United States, 10021 | |
Contact: Melissa La Mar 212-327-7280 mlamar@rockefeller.edu |
Principal Investigator: | Martin M Markowitz, MD | Rockefeller University |
Additional Information:
Responsible Party: | Rockefeller University |
ClinicalTrials.gov Identifier: | NCT00219947 History of Changes |
Other Study ID Numbers: |
MMA-448 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | January 11, 2018 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Rockefeller University:
HIV Infection Acute HIV Infection Primary HIV Infection Acute Seroconversion Syndrome |
Additional relevant MeSH terms:
Infection 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 |