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Analysis of Telmisartan Administered With Antiretroviral Therapy (ART) in Patients With Acute HIV Infection (SEARCH018)
This study is currently recruiting participants.
Verified January 2015 by Serena Spudich, MD, Yale University
Sponsor:
Yale University
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
South East Asia Research Collaboration with Hawaii
University of California, San Francisco
Walter Reed Army Institute of Research (WRAIR)
University of Hawaii
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Serena Spudich, MD, Yale University
ClinicalTrials.gov Identifier:
NCT02170246
First received: May 22, 2014
Last updated: January 22, 2015
Last verified: January 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Acute HIV Infection HIV Infections | Drug: Telmisartan | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) |
| 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] |
Resource links provided by NLM:
Further study details as provided by Serena Spudich, MD, Yale University:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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.
- 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.
- 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).
- 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.
| Estimated Enrollment: | 21 |
| Study Start Date: | August 2014 |
| Estimated Study Completion Date: | February 2019 |
| Estimated Primary Completion Date: | February 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
|
|
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).
|
Drug: Telmisartan |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02170246
Please refer to this study by its ClinicalTrials.gov identifier: NCT02170246
Locations
| Thailand | |
| Chulalongkorn University Hospital | Recruiting |
| Bangkok, Thailand, 10330 | |
| Contact: Nittaya Phanuphak, MD, PhD 66 2 254 2566 Nittaya.p@trcarc.org | |
| Principal Investigator: Nittaya Phanuphak, MD, PhD | |
| Thai Red Cross AIDS Research Centre | Recruiting |
| Bangkok, Thailand, 10330 | |
| Contact: Nittaya Phanuphak, MD, PhD 66 2 254 2566 Nittaya.P@trcarc.org | |
| Principal Investigator: Nittaya Phanuphak, MD, PhD | |
Sponsors and Collaborators
Yale University
National Institute of Neurological Disorders and Stroke (NINDS)
South East Asia Research Collaboration with Hawaii
University of California, San Francisco
Walter Reed Army Institute of Research (WRAIR)
University of Hawaii
National Institute of Mental Health (NIMH)
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 |
More Information
Additional Information:
| Responsible Party: | Serena Spudich, MD, Associate Professor of Neurology, Yale School of Medicine, Yale University |
| ClinicalTrials.gov Identifier: | NCT02170246 History of Changes |
| Other Study ID Numbers: |
1R01NS084911-01 ( U.S. NIH Grant/Contract ) W81XWH-11-2-0174 ( Other Identifier: Henry M. Jackson Foundation Cooperative Agreement ) R01MH095613 ( U.S. NIH Grant/Contract ) |
| Study First Received: | May 22, 2014 |
| Last Updated: | January 22, 2015 |
Keywords provided by Serena Spudich, MD, Yale University:
|
Acute HIV infection Central nervous system Antiretroviral therapy Telmisartan Cerebrospinal fluid |
Additional relevant MeSH terms:
|
Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Telmisartan Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 17, 2017