Analysis of Telmisartan Administered With Antiretroviral Therapy (ART) in Patients With Acute HIV Infection

Yale University21 enrolled

Overview

This research project will study whether the drug telmisartan administered in conjunction with antiretroviral therapy (ART) will help reduce nervous system infection with HIV. The investigators are studying the effect of this treatment in people who have contracted HIV infection within the past three weeks, and thus have a form of HIV called acute HIV infection. The investigators will measure biological markers of immune activation in the blood and cerebrospinal fluid to see if telmisartan may reduce the spread of HIV reservoirs in affected patients.

Note regarding the primary purpose of the study: In the Study Design section, this protocol is classified as "Other", since it is specifically designed to examine the effect of telmisartan administered in conjunction with ART on the size of HIV reservoirs in the central nervous system.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Acute HIV Infection HIV Infections

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years old * Have protocol-defined acute HIV-1 infection * Be part of the SEARCH 010/RV 254 study in Bangkok, Thailand * Ability and willingness to start ART immediately after diagnosis * Availability for follow-up for the duration of the planned study * Systolic blood pressure ≥ 110 mmHg * Agree to undergo lumbar puncture at weeks 0, 48 and 72 * Ability and willingness to provide informed consent. Subjects must understand the study and sign the consent form. Persons who cannot read will have the consent form read to them by a member of the study staff and may then give informed consent by using making a thumb print. Exclusion Criteria: * Pregnancy (current or within the last 6 months) or breastfeeding * Uncontrolled hypertension * Use of thiazolidinediones or other angiotensin receptor blockers class \[losartan, irbesartan, olmesartan, valsartan, candesartan (washout permitted)\] * Screening laboratory values: absolute neutrophil count \< 750 cells/mm3, hemoglobin \<10 gm/dL creatinine clearance \<30 mL/min (estimated by the Cockcroft-Gault equation using ideal body weight) * Known renal artery stenosis * Known cirrhosis or severe liver disease * Unstable coronary artery disease/angina or decompensated congestive heart failure * Any history of intolerance to any angiotensin receptor blocker * Need for ongoing potassium supplementation * Any contraindication to lumbar puncture such as history of bleeding diathesis or cerebral mass lesion

Outcomes

Primary Outcomes

Change in level of neopterin in the cerebrospinal fluid (CSF) of patients placed on antiretroviral therapy (ART) administered in conjunction with telmisartan, versus those placed on ART only

Neopterin is a biological marker of immune activation. Its presence in the CSF provides information on the establishment and persistence of HIV viral reservoirs within the central nervous system of HIV-positive patients.