SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era (SCOPE)

September 4, 2026 updated by: University of California, San Francisco

SCOPE is an observational, prospective study of HIV-1 infected volunteers designed to provide a specimen bank of samples with carefully characterized clinical data. SCOPE specimens will be used to examine multiple questions involving virologic, immunologic, and host factors involved in HIV-1 infection, progression, non-progression, response to treatment, control of HIV-1 virus, and evolution of drug resistance.

Study Overview

Status

Recruiting

Conditions

HIV Infections

Detailed Description

SCOPE is an observational, prospective study of HIV-1 infected volunteers designed to provide a specimen bank of samples with carefully characterized clinical data. Samples from SCOPE will be used to examine:

Virologic, immunologic, and host factors involved in the natural control of HIV-1 infection (long term non-progression and/or virologic control of HIV-1 without antiretroviral therapy)
Virologic and immune correlates associated with disease progression
Evolution of antiretroviral drug resistance
Factors associated with transmission or acquisition of HIV infection

Enrolled subjects are seen at San Francisco General Hospital every four months for a detailed interview, saliva collection, and blood draw. Baseline visits take approximately one hour, follow up visits take approximately 20-40 minutes. No personal identifiers are used for specimen bank samples.

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Rebecca Hoh, M.S., R.D.
Phone Number: 139 415-476-4082
Email: Rebecca.Hoh@ucsf.edu

Study Contact Backup

Name: Montha Pao
Phone Number: 140 415-476-4082
Email: Montha.Pao@ucsf.edu

Study Locations

United States
- California
  - San Francisco, California, United States, 94110
    - Recruiting
    - San Francisco General Hospital
    - Contact:
      
      Montha Pao
      
      Phone Number: 140 415-476-4082
      
      Email: Montha.Pao@ucsf.edu
    - Contact:
      
      Rebecca Hoh, M.S.
      
      Phone Number: 139 415-476-4082
      
      Email: Rebecca.Hoh@ucsf.edu
    - Principal Investigator:
      
      Steven G. Deeks, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

The study is open to eligible subjects who are able to perform study visits at San Francisco General Hospital or the San Francisco VA Medical Center.

Description

Inclusion Criteria:

SCOPE is currently recruiting HIV-1 infected subjects with any of the following criteria:

Documented HIV viral load less than 2000 copies/ml WITHOUT taking antiretroviral therapy
Undetectable HIV viral load with CD4 T-cells consistently less than 350 for the last 12 months while taking a stable antiretroviral regimen.
Antiretroviral naive and planning to start an antiretroviral regimen - any CD4 or HIV viral load acceptable.
Long-term Non Progressors: HIV-positive at least 10 years, no antiretroviral therapy for the past 10 years or more, any viral load acceptable, CD4-T cell count always above 500.

Exclusion Criteria:

Active opportunistic infection or systemic treatment for opportunistic infection within the last 4 months (oral candidiasis acceptable)
Active treatment for cancer
Active treatment for hepatitis C requiring interferon based therapy
Immunosuppressive therapy taken within the last 4 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The general theme of this core is to investigate the relationship between the virologic response to antiretroviral therapy and clinical outcome. Time Frame: Ongoing	Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator: Steven G. Deeks, M.D., University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria