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Telmisartan

Phase 2

HIV-1 Infection | Small molecule | Infectious Disease |cbdMD, Inc.|Last Updated: Aug 3, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment58

FDA Designations

No designations recorded

Clinical trial landscape

Telmisartan · 1 trial · 1 indication

Phase 2 1
NCT01928927Telmisartan to Reduce AIDS-Related Fibrotic and Inflammatory Contributors (TRAFIC Study)HIV-1 Infection
COMPLETED58 Analytics
PHASE2COMPLETED
Telmisartan to Reduce AIDS-Related Fibrotic and Inflammatory Contributors (TRAFIC Study)
HIV-1 InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48
baseline and week 48

Percent collagen I deposition is defined as the average % collagen stained in multiple uniform sized high magnification images in each sample. Change was absolute change defined as the Week 48 value minus the baseline value.

Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
baseline and week 48

Percent collagen I deposition defined as percentage of fibrotic/collagen area to total area. Change was absolute change defined as the Week 48 value minus the baseline value.

Secondary Endpoints

Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48
baseline and week 48
Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
baseline and week 48
Change in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
baseline and week 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A: TelmisartanEXPERIMENTAL -
Arm B: No Study DrugNO_INTERVENTIONParticipants received no study drug and followed the week 0-48 evaluation schedule.

Interventions

NameTypeDescription
TelmisartanDRUGParticipants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Step 1 Inclusion Criteria: * HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to Step 1 entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV a...

Countries:United StatesPuerto Rico
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Frequently asked questions about Telmisartan

What is Telmisartan used for in HIV-1 Infection?

Telmisartan is being studied for use in HIV-1 Infection. It is an investigational small molecule being developed by cbdMD, Inc. (YCBD) as a potential treatment to reduce AIDS-related fibrotic and inflammatory contributors in patients with HIV-1 infection. It is currently in Phase 2 clinical development.

What does Telmisartan target?

Telmisartan is an angiotensin II receptor blocker that targets the angiotensin II type 1 receptor. By blocking this receptor, it may reduce fibrosis and inflammation associated with HIV-1 infection. This mechanism is being evaluated in the TRAFIC study for its potential to address HIV-related complications.

Who makes Telmisartan?

Telmisartan is being developed by cbdMD, Inc., a company traded under the ticker YCBD. The company is conducting clinical research to evaluate the drug's potential in treating HIV-1 infection. The development program is currently in Phase 2.

What phase is Telmisartan in?

Telmisartan is in Phase 2 clinical development for HIV-1 Infection. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, with results informing the ongoing development program.

What clinical trials is Telmisartan in?

Telmisartan has one completed Phase 2 clinical trial, NCT01928927, titled 'Telmisartan to Reduce AIDS-Related Fibrotic and Inflammatory Contributors (TRAFIC Study)'. This trial enrolled 58 participants with HIV-1 Infection in the United States and Puerto Rico, and was a randomized, no-treatment controlled study.

Is Telmisartan the same as any other drug?

Telmisartan is a generic name for an angiotensin II receptor blocker that is also marketed under brand names such as Micardis. In the context of this development program, it is being repurposed for HIV-1 Infection by cbdMD, Inc. under the same chemical entity.