NCT00444847

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
Last Updated

July 27, 2017

Status Verified

March 1, 2007

First QC Date

March 7, 2007

Last Update Submit

July 26, 2017

Conditions

AIDS

Keywords

AIDSHIVHyperbaric Chambertreatment experienced

Outcome Measures

Primary Outcomes (3)

  • 1 - Safety

  • 2 - Viral Load measure (blood and intracellular)

  • 3 - CD4/CD8 levels

Secondary Outcomes (1)

  • ADL measurements

Interventions

Hyperbaric chamberDEVICE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CD4 count \<200
  • Viral load \> 5000

You may not qualify if:

  • Opportunistic infection
  • Concurrent neoplasm (see protocol)
  • Immunomodulators
  • HIV vaccination
  • Investigational HIV drugs (see protocol)
  • Pregnant women
  • Major organ transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Stephen D. Guthrie, MD, PhD

    Designed Altobaric Environment Technology

    PRINCIPAL INVESTIGATOR

  • Stephen G Guthrie, MD, PhD

    Designed Altobaric Environment Technology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 8, 2007

Study Start

July 1, 2005

Last Updated

July 27, 2017

Record last verified: 2007-03

Locations

US(1)