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NCT Number: NCT02170246

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

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.

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Key information

Conditions

Acute HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chulalongkorn University Hospital, Bangkok, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telmisartan

Drug

Primary outcomes

  1. 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

    Time frame: Change from baseline to 48 weeks following ART initiation

    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.

Secondary outcomes

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

    Time frame: Change from baseline to 48 weeks following ART initiation

    Will assess CSF levels of MCP-1, IP-10, and HIV RNA. Absolute levels of these compounds will be compared between subjects on ART + telmisartan versus those on ART only.

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

    Time frame: Change from baseline to 48 weeks following ART initiation

    Will assess blood plasma levels of these biomarkers in subjects on ART + telmisartan versus those on ART only.

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

    Time frame: Change from baseline to 48 weeks following ART initiation

    These measurements will be made using magnetic resonance spectroscopy (MRS).

  4. Test scores on HIV neuropsychological battery

    Time frame: Change from baseline to 48 weeks following ART initiation

    The assessments to be used in this study have been tested for use with native Thai speakers and will be consistent with other SEARCH study tests. SEARCH employs a HIV neurocognitive battery designed to minimize cultural bias, which has been tested in Bangkok.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • SEARCH Research Foundation
  • University of California, San Francisco
  • University of Hawaii
  • Walter Reed Army Institute of Research (WRAIR)

Registry information

Official study 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]

Acronym: SEARCH018

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2014
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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