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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• The general theme of this core is to investigate the relationship between the virologic response to antiretroviral therapy and clinical outcome. [Срок оценки: Ongoing]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• San Francisco General Hospital — San Francisco

Публикации

• 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. PMID 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. PMID 21200021

Идентификаторы

NCT: NCT00187512 · 10-01330

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗