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

Sponsor

Designed Altobaric Technology, Incorporated (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00444847

Collaborator

(none)

Enrollment

Location

Study Details

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

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 :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

1 - Safety []
2 - Viral Load measure (blood and intracellular) []
3 - CD4/CD8 levels []

Secondary Outcome Measures

ADL measurements []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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