Dasatinib for HIV-1 Reservoir Reduction
ConditionHIV Infections
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
This study will test if the medicine dasatinib can lower the hidden amount of HIV in the body, called the HIV "reservoir." It will also check if dasatinib is safe and easy to take for people living with HIV who have a suppressed viral load while on antiretroviral therapy (ART). Adults 18 years or older who have been on ART for at least 48 months and have had a suppressed HIV-1 viral load for at least 36 months may be able to join.
People will be randomly assigned to take dasatinib 100 mg by mouth once a day or a look-alike substance with no drug, called a placebo, for 12 weeks. Neither participants nor researchers will know who gets which (double-blind). The study team will do regular health checks and blood tests to track safety, tolerability, the HIV reservoir, and changes in immune cells.
The study lasts 36 weeks total: 12 weeks of treatment and 24 weeks of follow-up, with clinic visits and possible phone calls. Fourteen people will take part; eight will get dasatinib and six will get placebo. Dasatinib may lower the HIV reservoir, but this is not guaranteed. All medicines can cause side effects, called adverse events (AE). The study team will watch closely and provide medical support. Joining is your choice, and you can leave at any time. If you leave, the team will talk with you about next steps for your care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
HIV-1 infection
Active antiretroviral therapy received continuously for 48 months (or longer)
CD4+ cell count >450 cells/mm3 obtained within 12 months prior to study entry
Plasma HIV-1 RNA level below the lower limit of quantification within 90 days prior to study entry
Disqualifiers
Pre-ART viral load known to be <2000 copies/mL (HIV controller)
Known to have initiated ART during acute HIV infection
Presence of a drug-resistant virus with no alternative ART regimens available in the event that current ART regimen becomes compromised as a result of this study
Current pregnancy or breastfeeding or pregnancy planning during study participation
Trial design
Design model
Parallel
Treatments tested in this trial
Dasatinib
Drugwill be administered as one 100 mg capsule (over-encapsulated tablet) orally once daily for 12 weeks
Placebo
Other interventionPlacebo for dasatinib will be administered as one placebo capsule (over-encapsulated tablet) orally once daily for 12 weeks
Treatment groups
14 Participants
are divided into 2 treatment groupsGroup A: Arm 1: dasatinibExperimental treatment 1 intervention
Group B: Arm 2: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in intact HIV-1 reservoir size
Change in the intact HIV-1 reservoir from baseline to week 12, measured by the Intact Proviral DNA Assay (IPDA), or the best available assay at the time of testing if IPDA is not available.
Time frame
Baseline and week 122
Number of Study treatment-related adverse events
Occurrence of any study treatment-related serious adverse event (SAE), any Grade 2 or higher adverse event (AE), or any AE that leads to permanent discontinuation of study treatment, regardless of grade.
Time frame
From first dose through week 36Secondary outcomes
1
Anti-proliferative effects after 1 week of dasatinib
Change in immune cell proliferation after 1 week of dasatinib, compared with baseline. Proliferation will be assessed in CD4+ and/or CD8+ T cells using standard markers or assays
Time frame
Baseline and week 12
Changes in T cell subset composition and cellular Ki-67 expression
Changes from baseline to week 12 in T cell subset composition and Ki-67 expression.
Time frame
Baseline to week 123
Changes in HIV-1 cell-associated RNA transcripts in total CD4+ T cells
Measured in total CD4+ T cells
Time frame
Baseline to week 124
Changes in low-level plasma viremia (single-copy assay)
Measured using the single-copy assay
Time frame
Baseline to week 12Sponsors and contacts
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Source ClinicalTrials.gov