HIV CoinfectionPhase 1/2MSPB_TBNCT05065905
Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis
A Phase 1/2 study testing Interferon-Gamma in people with HIV Coinfection and Aids/Hiv Problem, run by SPP Pharmaclon Ltd. at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HIV Coinfection, Aids/Hiv Problem, Tuberculosis, Pulmonary
- What is being tested?
- Interferon-Gamma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesRussia
- Study dates
- 19 Jan 2006to 6 Apr 2006
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Saint-Petersburg State Medical Academy n.a. I.I.Mechnikov of Ministry of Health
Saint Petersburg, Sankt-Peterburg, 195067
City Tuberculosis Hospital #2 of Saint-Petersburg
Saint Petersburg, Sankt-Peterburg
About this study
Official title: A I//II Phase Study of the Efficacy and Safety of Interferon-Gamma by Subcutaneous Injection in the Complex Treatment of Patients Infected With HIV and Tuberculosis
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.
Read the detailed description
Study will evaluate safety and efficacy of the investigational medical product (IMP) - interferon-gamma - in participants with HIV-infection and pulmonary tuberculosis.
Interferon-gamma (immune interferon) is an important anti-inflammatory cytokine produced by NK-cells, CD4 Th1 cells and CD8 cytotoxic supressor cells. Interferon-gamma blocks viral replication, viral proteins synthesis and assembly of mature viral particles. Causes cytotoxic effects on the cells infected by intracellular pathogens. Possess a bright immunomoduling action. Thus, the use of interferon-gamma is patogenetically rational in patients co-infected with tuberculosis and HIV.
The aim of interferon-gamma use is to achieve a viral replication control, support CD4 level and help abacillation process. In this randomised, controlled safety and efficacy study interferon gamma will be administered in a daily dose of 500,000 IU daily or every other day.
The treatment regimen in this study will also include a basic antituberculosis therapy.
The available clinical data do not suggest a risk for serious adverse events (SAEs) from the IMP used in chosen doses.
The study will screen HIV-infected participants 18-50 years old with pulmonary tuberculosis. Participants who provide informed consent and meet study entry criteria will be randomised into 1 of 3 parallel treatment groups. The study will last 30 days, during which participants will receive IMP in various regimens according to the group.
- Conditions
- HIV Coinfection, Aids/Hiv Problem, Tuberculosis, Pulmonary, Human Immunodeficiency Virus, Lentivirus Infections, RNA Virus Infections
- Being tested
- Interferon-Gamma
- Keywords
- interferon gamma, IFN-g, HIV infection, tuberculosis
- Medical subject headings
- HIV Infections, Tuberculosis, Pulmonary, Acquired Immunodeficiency Syndrome, Lentivirus Infections, RNA Virus Infections, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-GammaDrug
Also called Ingaron, Interferon gamma human recombinant
received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein
| Study group | Role | What they receive |
|---|---|---|
| Interferon | Experimental | All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day
Interventions:
Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy Receives: Drug: Interferon-Gamma |
| Interferon daily | Experimental | All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day
Interventions:
Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy Receives: Drug: Interferon-Gamma |
| Control | No intervention | All participants receive only basic antimicrobial treatment Interventions: Drug: Antituberculosis complex therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum Culture
Precentage of participants with negative sputum culture
Measured: Week 4
Secondary outcomes (6)
Average Hemoglobin Level
Level of hemoglobin (g/L)
Measured: Screening, Week 8
Leucocytes Level
Number of leukocytes
Measured: Screening, Week 4
CD3
CD3 cells level in absolute numbers and percents
Measured: Screening, Week 4
CD4
CD4 cells level in absolute numbers and percents
Measured: Screening, Week 4
CD8
CD8 cells level in absolute numbers and percents
Measured: Screening, Week 4
CD4/CD8
Immunoregulatory index value
Measured: Screening, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start19 Jan 2006
- Primary completion29 Mar 2006
- Study completion6 Apr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV CoinfectionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPP Pharmaclon Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- North-Western State Medical University named after I.I.Mechnikov
- Responsible party
- Sponsor
- Investigators
- Vladimir Shmelev, Doctor, Study director, SPP Pharmaclon Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065905
- Sponsor's protocol ID
- MSPB_TB
- Acronym
- MSPB_TB
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 25 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A I//II Phase Study of the Efficacy and Safety of Interferon-Gamma by Subcutaneous Injection in the Complex Treatment of Patients Infected With HIV and Tuberculosis
- ClinicalTrials.gov ID
- NCT05065905
- Acronym / sponsor ID
- MSPB_TB / MSPB_TB
- Conditions
- HIV Coinfection, Aids/Hiv Problem, Tuberculosis, Pulmonary, Human Immunodeficiency Virus, Lentivirus Infections, RNA Virus Infections
- Keywords
- interferon gamma, IFN-g, HIV infection, tuberculosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- SPP Pharmaclon Ltd.Industry (pharma, biotech, devices)
- Collaborators
- North-Western State Medical University named after I.I.Mechnikov
- Study start
- 19 Jan 2006 (actual)
- Primary completion
- 29 Mar 2006 (actual)
- Study completion
- 6 Apr 2006 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Posted 25 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study will evaluate safety and efficacy of the investigational medical product (IMP) - interferon-gamma - in participants with HIV-infection and pulmonary tuberculosis.
Interferon-gamma (immune interferon) is an important anti-inflammatory cytokine produced by NK-cells, CD4 Th1 cells and CD8 cytotoxic supressor cells. Interferon-gamma blocks viral replication, viral proteins synthesis and assembly of mature viral particles. Causes cytotoxic effects on the cells infected by intracellular pathogens. Possess a bright immunomoduling action. Thus, the use of interferon-gamma is patogenetically rational in patients co-infected with tuberculosis and HIV.
The aim of interferon-gamma use is to achieve a viral replication control, support CD4 level and help abacillation process. In this randomised, controlled safety and efficacy study interferon gamma will be administered in a daily dose of 500,000 IU daily or every other day.
The treatment regimen in this study will also include a basic antituberculosis therapy.
The available clinical data do not suggest a risk for serious adverse events (SAEs) from the IMP used in chosen doses.
The study will screen HIV-infected participants 18-50 years old with pulmonary tuberculosis. Participants who provide informed consent and meet study entry criteria will be randomised into 1 of 3 parallel treatment groups. The study will last 30 days, during which participants will receive IMP in various regimens according to the group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interferon | Experimental | Drug: Interferon-GammaAll participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy |
| Interferon daily | Experimental | Drug: Interferon-GammaAll participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy |
| Control | No intervention | –All participants receive only basic antimicrobial treatment Interventions: Drug: Antituberculosis complex therapy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Interferon-GammaAlso: Ingaron, Interferon gamma human recombinantreceived by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein | Drug | Interferon, Interferon daily |
Primary outcome
Sputum Culture
Time frame: Week 4
Precentage of participants with negative sputum culture
6 secondary outcomes
Average Hemoglobin Level
Time frame: Screening, Week 8
Leucocytes Level
Time frame: Screening, Week 4
CD3
Time frame: Screening, Week 4
CD4
Time frame: Screening, Week 4
CD8
Time frame: Screening, Week 4
CD4/CD8
Time frame: Screening, Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Vladimir Shmelev, Doctor study director
SPP Pharmaclon Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Interferon-Gamma in people with HIV Coinfection and Aids/Hiv Problem, run by SPP Pharmaclon Ltd. at 2 sites in Russia.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 25 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sputum Culture (time frame: Week 4). 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 25 Jan 2024.