Problems With Immune Recovery in the Gut Tissue
This study has been completed.
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01460433
First received: October 24, 2011
Last updated: September 4, 2014
Last verified: September 2014
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Purpose
The aim of this study is to find out if the process of HIV replication in the lymph tissue and gut tissue of people taking HIV drugs causes long-term damage to the ability of the gut to protect you from other infections and health problems.
| Condition | Intervention |
|---|---|
|
Human Immunodeficiency Virus |
Procedure: Genital and rectal swabbing |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution (C) |
Resource links provided by NLM:
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- Herpes Simplex Virus - Type 2 shed rate [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evidence of HIV replication in blood and lymphoid tissue [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Blood, lymphatic tissues and anogenital swabs.
| Enrollment: | 21 |
| Study Start Date: | September 2008 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Procedure: Genital and rectal swabbing
Subjects swabs their genitals and rectum daily. The amount of HSV shed over the previous 24 hours is measured and the daily HSV shed rate is calculated.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV+, antiretroviral-treated individuals who have been exposed to Herpes Simplex Type 2 and Cytomegalovirus and HIV- individuals who have been exposed to Herpes Simplex Type 2 and Cytomegalovirus.
Criteria
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
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: NCT01460433
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460433
Locations
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
| Principal Investigator: | Timothy Schacker, MD | University of Minnesota - Clinical and Translational Science Institute |
More Information
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 |
| Study First Received: | October 24, 2011 |
| Last Updated: | September 4, 2014 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on September 26, 2016