Human Immunodeficiency Virus
Conditions
Keywords
HIV 1, Herpes Simplex Type 2, Treatment experienced
Brief summary
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.
Interventions
PROCEDUREGenital 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.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Herpes Simplex Virus - Type 2 shed rate | 60 days |
Secondary
| Measure | Time frame |
|---|---|
| Evidence of HIV replication in blood and lymphoid tissue | 60 days |
Countries
United States
Outcome results
None listed