Effect of Repeated Exposures to Compressed Air on Patients With AIDS - Full Text View

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

This study has been suspended.

( Change in institutional headquarters for the US study. )

First Received: March 7, 2007 Last Updated: April 2, 2007 History of Changes

Sponsored by:	Designed Altobaric Non-Atmospheric Environmental Technology
Information provided by:	Designed Altobaric Non-Atmospheric Environmental Technology
ClinicalTrials.gov Identifier:	NCT00444847

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 II

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Effect of Repeated Exposure to Compressed Air on Patients With AIDS (Acquired Immunodeficiency Syndrome)

Further study details as provided by Designed Altobaric Non-Atmospheric Environmental Technology:

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 Non-Atmospheric Environmental Technology

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

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

Keywords provided by Designed Altobaric Non-Atmospheric Environmental Technology:

AIDS
HIV
Hyperbaric Chamber
treatment experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 06, 2009