NCT05514899Toboroz2. fázis
Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV
Effects of Cannabidiol and Tetrahydrocannabinol on the Microbiome, Endocannabinoids, and Neuroinflammation in HIV
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 1.
Rövid összefoglaló (regiszter, angolul)
This study has the potential to contribute to a more complete understanding of the independent and combined effects of cannabis use and HIV on the brain and on inflammation. Such knowledge may inform future strategies for treating brain disease and inflammation. Participants will be randomly assigned to one of two groups, both of which will receive the same treatment in a different order over a period of about 6 weeks. The visits include physical examinations, blood tests, and other procedures designed to monitor subject safety and measure the effects of the study drug.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 90 (tervezett)
- Első benyújtás
- 2022. aug. 22.
- Kezdés
- 2023. szept. 1.
- Elsődleges befejezés
- 2027. okt. 31.
- Fő szponzor
- University of California, San Diego
- Betegségek
- HIV-fertőzés
- NCT-szám
- NCT05514899
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 90
- 2023. szept. 1. és az elsődleges befejezés (2027. okt. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Pregnancy or lactation, or unwillingness to prevent pregnancy during the trial; refusal to maintain highly effective contraceptive methods (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner) during the study for persons of child-bearing potential or those with partners of child-bearing potential
- Use of medications with absolute contraindicated or potential significant interactions
- Use of sedating medications
Más betegség
- Exclusion criteria will be: any substance use disorder (abuse or dependence) other than cannabis in the last 30 days;
- Significant cognitive impairment such as Dementia, including Alzheimer's disease
- Evidence of significant cardiovascular risk, resting heart rate <50 or >110 beats per minute, uncontrolled hypertension (systolic blood pressure <80 or >140 mmHg; diastolic blood pressure <50 or >90 mmHg), history of myocardial infarction, congestive heart failure, or arrhythmia);
- Evidence of chronic pulmonary disease requiring supplemental oxygen;
- Allergy to the study drugs or any of their constituents including sesame
- Active, uncontrolled psychiatric disorder with psychotic features, severe depression, or suicidality; Participants will be excluded if they have had a history of suicide attempt, recent suicidal ideation or behavior as indexed by their Beck Depression Inventory-II (BDI-II) score is greater than or equal to 29 (severe depression).
- Neurologic disorder that could compromise interpretation of study findings, including uncontrolled seizure disorder (active seizures within the past 3 months), multiple sclerosis, Parkinson's disease, Alzheimer's disease, and recent (past 3 months) cerebral infarction or hemorrhage with neurological sequelae.
Laborértékek
- Evidence of moderately or worse compromised liver or kidney function, including moderate (Child-Hugh B) or severe (Child-Hugh C) hepatic impairment and AST and ALT above ULN and total bilirubin above ULN;
- Active, recent, or remote medical history of hepatobiliary-related illness, including elevated transaminase levels above 3 times the upper limit of normal accompanied by elevations in total bilirubin above 2 times the upper limit of normal at screening;
- Weighing less than 60 kg at screening to minimize the risk of elevated transaminases as a result of exposure to cannabidiol;
Egyéb
- Insulin dependent diabetics
A regiszterben nem jelölt feltételek
- Aged 21 to 70 years old
- Possess the capacity to provide informed consent to a set of neuromedical assessment procedures.
- Experience with cannabis use at least once in the past 5 years without major adverse effects (e.g., psychosis, syncope)
- No or low cannabis use in the past 2 weeks, defined as no cannabis exposure or use or use limited to only once in the past 2 weeks.
- Willing to abstain from use of cannabis, CBD, THC, or synthetic cannabinoids outside the study during the 6-week intervention
- Individuals with HIV must meet the following criteria
- Virally suppressed on stable ART for at least 6 months and have no more than 1 prior event of virologic failure (i.e., required change in ARTs due to virologic failure)
- Stage 1 or 2 infection
- Have a "normal" CD4 count defined as ≥350 cells/microliter
- No significant history of ART regimen adherence challenges
- Ability to adhere to the study visit schedule.
Életkor a regiszterben: 21 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| HIV Neurobehavioral Research Program (HNRP) | San Diego | Egyesült Államok | Toboroz |
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