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

July 26, 2017 updated by: Designed Altobaric Technology, Incorporated

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Detroit Receiving Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
ADL measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 8, 2007

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DANET HIV/AIDS Trial Q050021
  • FDA Q050021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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