NCT03895645|Enrolling By Invitation
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Sponsor study identifier
Secondary identifiers
observational
1,000
1 country
1
Study Start
November 4, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Background: The HIV research program is part of the National Institute of Allergy and Infectious Diseases. The program aims to learn more about HIV. It also aims to improve the health of people with HIV and create HIV vaccines. People enrolled in prior HIV studies provided samples or data. They consented for their samples or data to be used for future research. Researchers want to keep studying the stored samples and data. Objective: To give approved researchers access to stored samples and data after the study of sample origin is over. To do this with human subjects protection oversight by the NIH institutional review board (IRB). Eligibility: The study populations were defined by the protocols under which the samples or data were obtained: 11-I-0259, 13-I-0081, and 14-I-0011. Design: All participants consented to provide blood or other samples. Their consent included future use of the samples. Researchers will not contact participants without prior approval of the IRB or the original study protocol. Samples will be labeled with a code. They will not be labeled with information that identifies the participants. Participants data will be stored in computers. The computers will be protected with passwords. This protocol will be kept open as long as the samples or data can be used for future research. When there is no longer a need, the samples may be moved if the IRB approves this. Otherwise they will be destroyed. ...
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 27, 2019
Actual (reported)March 29, 2019
Actual (reported)November 4, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Continued analysis
The objective of this protocol is to continue to have human subjects' protection oversight by the NIH IRB while making stored specimens and/or data available to approved research laboratories and investigators after the study of specimen origin has been terminated. Continued analyses will be for the purpose of research, exploratory immunology, and infectious disease research within the original study objectives and consents under which the specimens and data were collected. Manuscript completion for the primary study objectives will also be covered under this or the original study protocol.
Ongoing
Participants on the studies' samples that are transferred to this protocol
Healthy volunteers
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892, United States
Mark Connors, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
First Submitted
March 27, 2019
First Posted
March 29, 2019
Study Start
November 4, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 30, 2026
Record last verified: 2025-12-02
Individual participant data that underlie the results reported in the article after deidentification
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Source: ClinicalTrials.gov.
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