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

Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute HIV Infection; HIV Infections

Intervention: Telmisartan (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Serena Spudich, MD, MA, Principal Investigator, Affiliation: Yale University
Jintanat Ananworanich, MD, PhD, Study Chair, Affiliation: U.S. Military HIV Research Program, Bethesda, Maryland
Nittaya Phanuphak, MD, PhD, Principal Investigator, Affiliation: Thai Red Cross AIDS Research Centre, Bangkok, Thailand


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.

Clinical Details

Official title: Adjunctive Therapy With Telmisartan Instituted With ART During Acute HIV Infection to Reduce the Establishment of Central Nervous System Reservoirs of HIV and Lymph Node Fibrosis [Southeast Asia Research Collaboration With Hawaii (SEARCH) 018]

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Primary outcome: 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

Secondary outcome:

Change in levels of mast cell progenitor-1 (MCP-1), IP-10, and HIV RNA in the cerebrospinal fluid (CSF)

Change in blood plasma levels of neopterin, interleukin-6, D-dimers, soluble cluster of differentiation 14 (sCD14), and soluble cluster of differentiation 163 (sCD163)

Change in absolute concentrations and ratios with respect to creatine of choline, myoinositol, and n-acetylaspartate (NAA) in specified brain regions

Test scores on HIV neuropsychological battery

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Chulalongkorn University Hospital, Bangkok 10330, Thailand; Recruiting
Nittaya Phanuphak, MD, PhD, Phone: 66 2 254 2566, Email: Nittaya.p@trcarc.org
Nittaya Phanuphak, MD, PhD, Principal Investigator

Thai Red Cross AIDS Research Centre, Bangkok 10330, Thailand; Recruiting
Nittaya Phanuphak, MD, PhD, Phone: 66 2 254 2566, Email: Nittaya.P@trcarc.org
Nittaya Phanuphak, MD, PhD, Principal Investigator

Additional Information

Website: South East Asia Research Collaboration with Hawaii

Starting date: August 2014
Last updated: January 22, 2015

Page last updated: August 23, 2015

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