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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NS084911-01 | U.S. NIH Grant/Contract | View source | |
| W81XWH-11-2-0174 | Other Identifier | Henry M. Jackson Foundation Cooperative Agreement | |
| R01MH095613 | U.S. NIH Grant/Contract | View source | |
| R01MH104141 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| SEARCH Research Foundation | OTHER |
| University of California, San Francisco | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antiretroviral Therapy (ART) only | No Intervention | 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. | |
| ART + Telmisartan | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug |
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| 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 | 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 from baseline to 48 weeks following ART initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in levels of mast cell progenitor-1 (MCP-1), IP-10, and HIV RNA in the cerebrospinal fluid (CSF) | 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 from baseline to 48 weeks following ART initiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Serena Spudich, MD, MA | Yale University | Principal Investigator |
| Jintanat Ananworanich, MD, PhD | U.S. Military HIV Research Program, Bethesda, Maryland | Study Chair |
| Nittaya Phanuphak, MD, PhD | Thai Red Cross AIDS Research Centre, Bangkok, Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn University Hospital | Bangkok | 10330 | Thailand | |||
| Thai Red Cross AIDS Research Centre |
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| Label | URL |
|---|---|
| Website: South East Asia Research Collaboration with Hawaii | View source |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Walter Reed Army Institute of Research (WRAIR) |
| FED |
| University of Hawaii | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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) |
Will assess blood plasma levels of these biomarkers in subjects on ART + telmisartan versus those on ART only. |
| Change from baseline to 48 weeks following ART initiation |
| Change in absolute concentrations and ratios with respect to creatine of choline, myoinositol, and n-acetylaspartate (NAA) in specified brain regions | These measurements will be made using magnetic resonance spectroscopy (MRS). | Change from baseline to 48 weeks following ART initiation |
| Test scores on HIV neuropsychological battery | 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. | Change from baseline to 48 weeks following ART initiation |
| Bangkok |
| 10330 |
| Thailand |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |