Problems With Immune Recovery in the Gut Tissue

NCT ID: NCT01460433

Last Updated: 2014-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Immunodeficiency Virus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Timothy Schacker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P01AI074340

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0712M22449

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exploration of HIV Reservoirs
NCT01019044 COMPLETED
Fecal Microbiota Transplantation in HIV
NCT02256592 COMPLETED PHASE1