Using Telmisartan With ART During Acute HIV Infection to Reduce the CNS Reservoirs of HIV and Lymph Node Fibrosis
Status:
Completed
Trial end date:
2018-02-01
Target enrollment:
Participant gender:
Summary
Primary objective: To compare telmisartan therapy + antiretroviral therapy (ART) versus ART
alone during acute Human Immunodeficiency Virus (HIV)a infection in reducing systemic immune
activation and trafficking of activated and HIV-infected cells to the central nervous system
(CNS), and limiting establishment and persistence of the CNS reservoir of HIV.
At 48 weeks (during the telmisartan therapy) and 72 weeks (~6 months after cessation of
telmisartan augmentation), the investigator expect subjects in the telmisartan group will
have reduced levels of blood and CSF immune activation markers, reduced brain inflammation,
lower CSF HIV ribonecleic acid (RNA) and improved neuropsychological testing performance.
Secondary objective: In subjects who are willing to undergo the optional inguinal lymph node
biopsy, the study will determine whether subjects receiving telmisartan plus ART for 48 weeks
develop less lymphoid tissue fibrosis than subjects receiving ART alone for 48 weeks.
Subject population: Male and female subjects age ≥ 18 years old with acute HIV infection who
are identified and enrolled in SEARCH 010/RV254 protocol will be asked to co-enroll in this
study.
Number of subjects: 21
Duration of follow-up: 72 weeks
Study design: 21 acutely HIV-infected subjects will be randomized 2:1 to treatment with
telmisartan + ART (n=14) vs. ART alone (n=7) for the first 48 weeks followed by ART alone in
both arms to week 72. Blood and CSF, magnetic resonance imaging (MRI), and neuropsychological
testing and exam will be collected at baseline, week 48 and week 72. Inguinal lymph node
biopsy is an optional procedure that will be offered at baseline and week 48.
Phase:
Phase 2
Details
Lead Sponsor:
South East Asia Research Collaboration with Hawaii
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)