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RecruitingNCT00187512SCOPEUpdated Sep 8, 2026

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

An observational study in HIV Infections, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,500
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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:

  1. 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)
  2. Virologic and immune correlates associated with disease progression
  3. Evolution of antiretroviral drug resistance
  4. 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.

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Conditions studied

  • HIV Infections

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Keywords

  • HIV
  • Antiretroviral Agents
  • Drug Resistance, Multiple
  • Long Term Non Progression
  • Long Term Non Progressor
  • Elite Suppression
  • Elite Suppressor
  • Natural History
  • Observational
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In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

  1. Documented HIV viral load less than 2000 copies/ml WITHOUT taking antiretroviral therapy
  2. Undetectable HIV viral load with CD4 T-cells consistently less than 350 for the last 12 months while taking a stable antiretroviral regimen.
  3. Antiretroviral naive and planning to start an antiretroviral regimen - any CD4 or HIV viral load acceptable.
  4. 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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. The general theme of this core is to investigate the relationship between the virologic response to antiretroviral therapy and clinical outcome.

    Time frame: Ongoing

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Study locations

1 of 1 sites recruiting
  • San Francisco General Hospital
    San Francisco, California 94110, United States
    Recruiting
08

References and documents

Publications

  • Meanley S, Rodriguez Garcia L, Lisha NE, Ahmed A, Korolkova A, Figueroa T, Nguyen E, J Peluso M, Cohn LB, Deeks S, Dube K, Sauceda J. Exploring Stigma and Self-Image: Mixed-Methods Insights from HIV Cure-Related Research Participants Undergoing Analytical Treatment Interruptions. AIDS Patient Care STDS. 2025 Apr;39(4):151-159. doi: 10.1089/apc.2024.0254. Epub 2025 Feb 20. PubMed 39973220 ↗
  • Favre D, Stoddart CA, Emu B, Hoh R, Martin JN, Hecht FM, Deeks SG, McCune JM. HIV disease progression correlates with the generation of dysfunctional naive CD8(low) T cells. Blood. 2011 Feb 17;117(7):2189-99. doi: 10.1182/blood-2010-06-288035. Epub 2011 Jan 3. PubMed 21200021 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00187512
Lead sponsor
University of California, San Francisco
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Mar 2000
Primary completion
Dec 2032 (estimated)
Completion
Dec 2033 (estimated)
Last update
Sep 8, 2026

Study contacts

Rebecca Hoh, M.S., R.D.
Contact
Rebecca.Hoh@ucsf.edu
415-476-4082 ext. 139
Montha Pao
Contact
Montha.Pao@ucsf.edu
415-476-4082 ext. 140
Steven G. Deeks, M.D.
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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