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New treatment option for HIV/AIDS
Official title SCOPE Analytic Treatment Interruption Protocol
ClinicalTrials.gov ID: NCT04359186
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willing and able to provide written informed consent
- Age \>= 18
- Documented HIV infection
- Antiretroviral therapy for at least 12 months
- Screening plasma HIV RNA levels below level of detection (\< 40-75 copies/mL), and all available determinations in past 12 months also below level of...
You likely can't join if
- Pregnant or plans to become pregnant during the course of the study
- Active hepatitis B, defined as (1) positive sAg or (2) positive cAb with negative sAb and positive HBV DNA
- Active hepatitis C, defined as positive Hep C Ab with positive HCV RNA
- Use of a non-nucleoside reverse transcriptase inhibitor and unable to switch regimen
- Significant cardiovascular or cerebrovascular disease
- Recent or prior (within past 5 years) malignancy
See the full eligibility criteria
- Willing and able to provide written informed consent
- Age \>= 18
- Documented HIV infection
- Antiretroviral therapy for at least 12 months
- Screening plasma HIV RNA levels below level of detection (\< 40-75 copies/mL), and all available determinations in past 12 months also below level of detection (blips allowed)
- Screening CD4+ T-cell count \>350 cells/uL
- If of childbearing potential, willing to use two methods of contraception
- Willing to receive counseling regarding HIV transmission risk mitigation
- Pregnant or plans to become pregnant during the course of the study
- Active hepatitis B, defined as (1) positive sAg or (2) positive cAb with negative sAb and positive HBV DNA
- Active hepatitis C, defined as positive Hep C Ab with positive HCV RNA
- Use of a non-nucleoside reverse transcriptase inhibitor and unable to switch regimen
- Significant cardiovascular or cerebrovascular disease
- Recent or prior (within past 5 years) malignancy
- Severe kidney disease (CrCl \< 50 mL/min via Cockroft-Gault method)
- Severe hepatic impairment (Child-Pugh Class C) or unstable liver disease
- Concurrent treatment with immunomodulatory drugs
- Unable or unwilling to use barrier protection or pre-exposure prophylaxis (PrEP) to prevent HIV transmission with sexual partners not known to be HIV-infected
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.