Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis

• Status: Completed
• Trial end date: 2006-04-06
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to assess the safety and efficacy of interferon-gamma by subcutaneous injection in complex treatment of patients with co-infection of HIV and pulmonary tuberculosis and to determine the rational of its use.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SPP Pharmaclon Ltd.
• Collaborator: North-Western State Medical University named after I.I.Mechnikov
• Treatments: Interferon-gamma; Interferons

Criteria

Inclusion Criteria:

• Participants must sign the form of informed consent and agree to follow the protocol requirements

• Women willing to participate in the study must protect against possible pregnancy during all the study long

• Age 18-50 years

• Pulmonary tuberculosis

• HIV/AIDS

• Indication for in-patient standard antituberculosis treatment

Exclusion Criteria:

• Investigational research agents received within 30 days before the screening and participation in other clinical trials

• Immunosuppressive medications received within 6 months before the screening

• Current drug abuse for more than 3 years

• Contraindications to interferons of standard antimicrobial therapy