- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02170246
Analysis of Telmisartan Administered With Antiretroviral Therapy (ART) in Patients With Acute HIV Infection (SEARCH018)
March 4, 2020 updated by: Yale University
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]
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bangkok, Thailand, 10330
- Chulalongkorn University Hospital
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Bangkok, Thailand, 10330
- Thai Red Cross Aids Research Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Antiretroviral Therapy (ART) only
Acute HIV-infected subjects (n=7) will be randomly assigned to a group that will receive antiretroviral therapy (the current standard of care for HIV patients) for 72 weeks.
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Experimental: ART + Telmisartan
Acute HIV-infected subjects (n=14) will be randomly assigned to a group that will receive treatment with telmisartan in addition to ART.
Subjects will receive 40mg telmisartan daily for 4 weeks, followed by 80mg telmisartan daily for 44 weeks, to be taken in conjunction with ART.
Subjects unable to tolerate 80mg of telmisartan will be able to de-escalate to 40mg daily.
After telmisartan is stopped, subjects will continue to take ART for an additional 24 weeks (total 72 weeks).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Change from baseline to 48 weeks following ART initiation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Change from baseline to 48 weeks following ART initiation
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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
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Will assess blood plasma levels of these biomarkers in subjects on ART + telmisartan versus those on ART only.
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Change from baseline to 48 weeks following ART initiation
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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
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These measurements will be made using magnetic resonance spectroscopy (MRS).
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Change from baseline to 48 weeks following ART initiation
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Test scores on HIV neuropsychological battery
Time Frame: Change from baseline to 48 weeks following ART initiation
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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.
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Change from baseline to 48 weeks following ART initiation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Serena Spudich, MD, MA, Yale University
- Study Chair: Jintanat Ananworanich, MD, PhD, U.S. Military HIV Research Program, Bethesda, Maryland
- Principal Investigator: Nittaya Phanuphak, MD, PhD, Thai Red Cross AIDS Research Centre, Bangkok, Thailand
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 28, 2015
Primary Completion (Actual)
June 13, 2018
Study Completion (Actual)
June 13, 2018
Study Registration Dates
First Submitted
May 22, 2014
First Submitted That Met QC Criteria
June 19, 2014
First Posted (Estimate)
June 23, 2014
Study Record Updates
Last Update Posted (Actual)
March 9, 2020
Last Update Submitted That Met QC Criteria
March 4, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Telmisartan
Other Study ID Numbers
- 1401013214
- 1R01NS084911-01 (NIH)
- W81XWH-11-2-0174 (Other Identifier: Henry M. Jackson Foundation Cooperative Agreement)
- R01MH095613 (U.S. NIH Grant/Contract)
- R01MH104141 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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