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

Designed Altobaric Technology

Status and phase: Withdrawn; Phase 2

Conditions: AIDS

Treatments: Device: Hyperbaric chamber

Study type: Interventional

Funder types: Other

Identifiers

NCT00444847

DANET HIV/AIDS Trial Q050021

FDA Q050021

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind