Analysis of HIV-1 Replication During Antiretroviral Therapy
This study will determine if the level of virus in HIV-infected patients taking antiretroviral medications for prolonged periods decreases or persists at a stable level. It will also examine whether new gene changes (mutations) occur during drug suppression.
HIV-infected patients who are 18 years of age or older, have been enrolled in another NIH protocol, have been suppressed on antiretroviral therapy and have very low levels of virus in their blood may be eligible for this 5-year (or more) study.
Participants come to the NIH Clinical Center about every 6 months for a physical examination, routine and research blood tests and leukapheresis to collect white blood cells for T cell analysis. For leukapheresis, blood is collected through a vein much like donating whole blood, but the blood is directed through a machine that separates and extracts the white cells and returns the rest of the blood components to the patient. Patients may also have an optional third clinic visit each year for another blood draw.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Analysis of HIV-1 Replication During Antiretroviral Therapy|
- We plan to investigate the relationship of HIV-1 viral RNA levels and genetic variation in patients on antiretroviral therapy over prolonged periods. [ Time Frame: End of Study ]
- 1. Investigate the determinants of HIV- 1 viremia in suppressed patients [ Time Frame: End of Study ]
- 3. Investigate the genetic and immunologic characteristics of patients with HIV-1 suppression on antiretroviral therapy who experience rebound viremia [ Time Frame: End of Study ]
- 2. Provide human subjects protection oversight for samples accrued in protocol 97-I-0082 and 00-I-0110 [ Time Frame: End of Study ]
|Study Start Date:||September 24, 2008|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767312
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Frank Maldarelli, M.D.||National Cancer Institute (NCI)|