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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00444847
Recruitment Status : Withdrawn
First Posted : March 8, 2007
Last Update Posted : July 27, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
AIDS Device: Hyperbaric chamber Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Effect of Repeated Exposure to Compressed Air on Patients With AIDS (Acquired Immunodeficiency Syndrome)
Study Start Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. ADL measurements

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): 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

ClinicalTrials.gov Identifier: NCT00444847     History of Changes
Other Study ID Numbers: DANET HIV/AIDS Trial Q050021
FDA Q050021
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: March 2007

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

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