Phase 2
N=78
Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis
HIV Coinfection · Aids/Hiv Problem · Tuberculosis, Pulmonary · Human Immunodeficiency Virus · Lentivirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT05065905 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Sputum Culture — 15; 20; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Interferon-Gamma (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- SPP Pharmaclon Ltd.
- Primary completion
- Mar 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sputum Culture |
15; 20; 14 | — |
| SECONDARY Average Hemoglobin Level |
— | — |
| SECONDARY Leucocytes Level |
— | — |
| SECONDARY CD3 |
— | — |
| SECONDARY CD4 |
— | — |
| SECONDARY CD8 |
— | — |
| SECONDARY CD4/CD8 |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05065905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.