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NCT00444847 Clinical Trial

Effect of Repeated Exposures to Compressed Air on Patients With AIDS

AIDS Clinical Trial

— DANET1  

Official title:
Effect of Repeated Exposure to Compressed Air on Patients With AIDS (Acquired Immunodeficiency Syndrome)

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00444847
Other study ID # DANET HIV/AIDS Trial Q050021
Secondary ID FDA Q050021
Status Withdrawn
Phase Phase 2
First received March 7, 2007
Last updated July 26, 2017
Start date July 2005

Study information
Verified date March 2007
Source Designed Altobaric Technology, Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Acquired Immunodeficiency Syndrome
  • AIDS

Intervention

Device:
• Hyperbaric chamber

Locations
Country Name City State
United States Detroit Receiving Hospital Detroit Michigan

Sponsors (1)
Lead Sponsor Collaborator
Designed Altobaric Technology, Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 1 - Safety
Primary 2 - Viral Load measure (blood and intracellular)
Primary 3 - CD4/CD8 levels
Secondary ADL measurements
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