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| Name | Class |
|---|---|
| Chan Zuckerberg Biohub | OTHER |
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The goal of this study is to understand the interaction between HIV and the host at the earliest stages when HIV medications are paused. Volunteers with HIV will interrupt antiretroviral therapy (ART) and then have intensive studies preformed two to three times per week. Most will resume therapy within three weeks, even if the virus does not rebound during this time.
In this study, people living with HIV will undergo intensive sampling prior to and following an interruption of their antiretroviral therapy (ART). Individuals will be asked to resume ART once the virus is detectable, or after approximately three weeks if the virus remains undetectable.
Individuals who were able to control their virus before ART ("controllers") will be able to participate in an extended treatment interruption and have less restrictive ART restart criteria.
The overall goal of the study is to characterize the interaction between the host and the virus at the earliest stages of virus replication and to identify predictors of rebound before virus becomes detectable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Interruption Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment Interruption Arm | Other | Individuals with HIV on suppressive ART will interrupt their ART. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute retroviral syndrome | The proportion of participants developing acute retroviral syndrome | Week 0 through Month 6 |
| Failure to re-suppress | The proportion of participants who fail to re-suppress to plasma HIV RNA levels <50 copies/mL after re-initiating ART | Week 0 through Month 12 |
| CD4+ T cell decline | The proportion of participants with confirmed decreases in CD4+ T cell count below 350 cells/uL | Week 0 through Month 6 |
| Time to rebound | The time between the treatment interruption and plasma HIV RNA >200 copies/mL | Week 0 through Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven Deeks, MD | Contact | 415-476-4082 | 404 | steven.deeks@ucsf.edu |
| Michael Peluso, MD | Contact | 415-476-9363 | michael.peluso@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Steven Deeks, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | Recruiting | San Francisco | California | 94110 | United States |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |