Analysis of Telmisartan Administered With Antiretroviral Therapy (ART) in Patients With Acute HIV Infection (SEARCH018)
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|ClinicalTrials.gov Identifier: NCT02170246|
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : March 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute HIV Infection HIV Infections||Drug: Telmisartan||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (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]|
|Actual Study Start Date :||January 28, 2015|
|Actual Primary Completion Date :||June 13, 2018|
|Actual Study Completion Date :||June 13, 2018|
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).
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02170246
|Chulalongkorn University Hospital|
|Bangkok, Thailand, 10330|
|Thai Red Cross AIDS Research Centre|
|Bangkok, Thailand, 10330|
|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|