Problems With Immune Recovery in the Gut Tissue
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ClinicalTrials.gov Identifier: NCT01460433 |
Recruitment Status
:
Completed
First Posted
: October 26, 2011
Last Update Posted
: September 5, 2014
|
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Condition or disease | Intervention/treatment |
---|---|
Human Immunodeficiency Virus | Procedure: Genital and rectal swabbing |
Study Type : | Observational |
Actual Enrollment : | 21 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution (C) |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |

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Procedure: Genital and rectal swabbing
- Herpes Simplex Virus - Type 2 shed rate [ Time Frame: 60 days ]
- Evidence of HIV replication in blood and lymphoid tissue [ Time Frame: 60 days ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
HIV+ individuals
- Seropositive for HIV
- On ART for at least 12 months
- Seropositive for Herpes Simplex Type 2 and Cytomegalovirus
- Age ≥ 18 years
- Negative pregnancy test for eligible women of childbearing potential
HIV- individuals
- Seronegative for HIV
- Seropositive for Herpes Simplex Type 2 and Cytomegalovirus
- Age ≥ 18 years
- Negative pregnancy test for eligible women of childbearing potential
Exclusion Criteria:
- Taking daily suppressive therapy for Herpes Simplex Type 2
- Contraindication to surgical & endoscopic procedures (as judged by PI)
- Psychiatric or psychological illness that would make adherence to protocol procedures unlikely
- Pregnancy

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): NCT01460433
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Timothy Schacker, MD | University of Minnesota - Clinical and Translational Science Institute |
Additional Information:
Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
ClinicalTrials.gov Identifier: | NCT01460433 History of Changes |
Other Study ID Numbers: |
0712M22449 P01AI074340 ( U.S. NIH Grant/Contract ) |
First Posted: | October 26, 2011 Key Record Dates |
Last Update Posted: | September 5, 2014 |
Last Verified: | September 2014 |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
HIV 1 Herpes Simplex Type 2 Treatment experienced |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |