Analysis of HIV-1 Replication During Antiretroviral Therapy

NCT00767312 | Enrolling By Invitation

• 2 other identifiers: 08022108-I-0221
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

HIV; Natural History

Outcome Measures

Primary Outcomes (1)

• We plan to investigate the relationship of HIV-1 viral RNA levels and genetic variation in patients on antiretroviral therapy over prolonged periods.

  HIV-1 viral RNA

  every 6 months

Secondary Outcomes (3)

• Provide human subjects protection oversight for samples accrued in protocol 97-I-0082 and 00-I-0110

  ongoing

• Investigate the genetic and immunologic characteristics of patients with HIV-1 suppression on antiretroviral therapy who experience rebound viremia

  ongoing

• Investigate determinants of HIV-1 DNA quantity and characteristics in suppressed patients

  ongoing

Study Arms (1)

Patients

HIV-infected patients who are 18 years of age or older, have been enrolled in another NIH protocol.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from studies: 00-I-0110 and 97-I-0082 are eligible for enrollment. Patients in other NIH studies would be considered for co-enrollment in this study if continued longitudinal sample acquisition is deemed desirable.

You may qualify if:

• Age greater than or equal to 18 years.
• HIV infection with documented reactive ELISA and positive western blot.
• Prior enrollment in 00-I-0110, 97-I-0082 OR patients with long term evaluation at NIH for whom additional sampling will be useful for protocol objectives, including:
• Available stored specimens from pretherapy period.
• Ongoing suppression of viremia with bDNA less than 50 copies/mL, OR
• Suppression of viremia to less than 50 copies/mL followed by rebound viremia during therapy.
• Patients must have a private physician for routine medical care.

You may not qualify if:

• Any prospective study subject who has been previously withdrawn from any prior study for inability to comply with study procedures will be considered ineligible for this study.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Frank Maldarelli, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 7, 2008
• Study Start: November 17, 2008
• Last Updated: May 22, 2026

Record last verified: 2025-09-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Identified data in BTRIS (automatic for activities in the Clinical Center and will be available for use following the BTRIS Policy for Data Sharing and Use).
• Access Criteria: Identified data in BTRIS (automatic for activities in the Clinical Center and will be available for use following the BTRIS Policy for Data Sharing and Use).@@@@@@@@@@@@De-identified or identified data with approved outside collaborators under appropriate agreements.

Locations

US (1)