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Summary

for people ages 18 years and up (full criteria)
study started
estimated completion:

Description

Summary

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.

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]

Details

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.

Keywords

Acute HIV Infection HIV Infections Central nervous system Antiretroviral therapy Telmisartan Cerebrospinal fluid Infection Communicable Diseases Acquired Immunodeficiency Syndrome

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Yale University
Links
Website: South East Asia Research Collaboration with Hawaii
ID
NCT02170246
Phase
Phase 1
Study Type
Interventional
Last Updated
January 2015