Effect of Repeated Exposures to Compressed Air on Patients With AIDS (DANET1)

This study has suspended participant recruitment.
(Change in institutional headquarters for the US study.)
Sponsor:
Information provided by:
Designed Altobaric Technology, Incorporated
ClinicalTrials.gov Identifier:
NCT00444847
First received: March 7, 2007
Last updated: April 2, 2007
Last verified: March 2007
  Purpose

The exposure of human beings to markedly altered environments (ambient pressure and inhaled gas mixtures) has profound effects on their innate immune capacity to effectively combat viral illnesses. This Phase IIA clinical trial examines the effects of an exposure to a 4 atmospheric environment has on HIV-infected humans whose clinical condition has progressed to formal AIDS status.


Condition Intervention Phase
AIDS
Device: Hyperbaric chamber
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Effect of Repeated Exposure to Compressed Air on Patients With AIDS (Acquired Immunodeficiency Syndrome)

Resource links provided by NLM:


Further study details as provided by Designed Altobaric Technology, Incorporated:

Primary Outcome Measures:
  • 1 - Safety
  • 2 - Viral Load measure (blood and intracellular)
  • 3 - CD4/CD8 levels

Secondary Outcome Measures:
  • ADL measurements

Study Start Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CD4 count <200
  • Viral load > 5000

Exclusion Criteria:

  • Opportunistic infection
  • Concurrent neoplasm (see protocol)
  • Immunomodulators
  • HIV vaccination
  • Investigational HIV drugs (see protocol)
  • Pregnant women
  • Major organ transplant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444847

Locations
United States, Michigan
Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Designed Altobaric Technology, Incorporated
Investigators
Principal Investigator: Stephen D. Guthrie, MD, PhD Designed Altobaric Environment Technology
Principal Investigator: Stephen G Guthrie, MD, PhD Designed Altobaric Environment Technology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00444847     History of Changes
Other Study ID Numbers: DANET HIV/AIDS Trial Q050021, FDA Q050021
Study First Received: March 7, 2007
Last Updated: April 2, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Designed Altobaric Technology, Incorporated:
AIDS
HIV
Hyperbaric Chamber
treatment experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014