AIDSPhase 2DANET1NCT00444847
Effect of Repeated Exposures to Compressed Air on Patients With AIDS
A Phase 2 study testing Hyperbaric chamber in people with AIDS, run by Designed Altobaric Technology, Incorporated at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- AIDS
- What is being tested?
- Hyperbaric chamber
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CD4 count <200
- Viral load > 5000
Who cannot join
- Opportunistic infection
- Concurrent neoplasm (see protocol)
- Immunomodulators
- HIV vaccination
- Investigational HIV drugs (see protocol)
- Pregnant women
- Major organ transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- AIDS
- Being tested
- Hyperbaric chamber
- Keywords
- AIDS, HIV, Hyperbaric Chamber, treatment experienced
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric chamberDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
1 - Safety
2 - Viral Load measure (blood and intracellular)
3 - CD4/CD8 levels
Secondary outcomes (1)
ADL measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Designed Altobaric Technology, Incorporated
- Sponsor type
- University, hospital or other
- Investigators
- Stephen D. Guthrie, MD, PhD, Principal investigator, Designed Altobaric Environment TechnologyStephen G Guthrie, MD, PhD, Principal investigator, Designed Altobaric Environment Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444847
- Sponsor's protocol ID
- DANET HIV/AIDS Trial Q050021
- Other IDs
- FDA Q050021
- Acronym
- DANET1
- Status last verified
- Mar 2007
- First submitted
- 7 Mar 2007
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeated Exposure to Compressed Air on Patients With AIDS (Acquired Immunodeficiency Syndrome)
- ClinicalTrials.gov ID
- NCT00444847
- Acronym / sponsor ID
- DANET1 / DANET HIV/AIDS Trial Q050021
- Conditions
- AIDS
- Keywords
- AIDS, HIV, Hyperbaric Chamber, treatment experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Designed Altobaric Technology, IncorporatedUniversity, hospital or other
- Study start
- Jul 2005
- First posted
- 8 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CD4 count <200
- Viral load > 5000
Key exclusion criteria (7 listed)
- Opportunistic infection
- Concurrent neoplasm (see protocol)
- Immunomodulators
- HIV vaccination
- Investigational HIV drugs (see protocol)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric chamber | Device | – |
Primary outcome
1 - Safety
2 - Viral Load measure (blood and intracellular)
3 - CD4/CD8 levels
1 secondary outcome
ADL measurements
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
Related trials for AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen D. Guthrie, MD, PhD principal investigator
Designed Altobaric Environment Technology
Stephen G Guthrie, MD, PhD principal investigator
Designed Altobaric Environment Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperbaric chamber in people with AIDS, run by Designed Altobaric Technology, Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 - Safety. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.