TuberculosisPhase 2NCT00057421
Tuberculosis in HIV Infected Patients in Uganda
A Phase 2 study testing prednisolone in people with Tuberculosis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Uganda.
Trial summary
This was a clinical trial in HIV infected patients with tuberculosis. The study assessed whether the addition of prednisolone, a type of steroid medication, to the standard treatment for tuberculosis improved immune and viral outcomes in the patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tuberculosis, HIV Infections
- What is being tested?
- prednisolone
- How many people
- 190 participants
- Where
- 1 siteUganda
- Study dates
- Nov 1998to Sep 2002
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pulmonary TB (smear positive)
- HIV infected
- Residence within 20 km of Kampala city
- Allows frequent blood specimens to be drawn
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Tuberculosis on HIV Infection in Uganda
This was a clinical trial in HIV infected patients with tuberculosis. The study assessed whether the addition of prednisolone, a type of steroid medication, to the standard treatment for tuberculosis improved immune and viral outcomes in the patients. The study demonstrated that prednisolone increased the CD4 cell count as was hoped, but the beneficial effect was short-lived and was gone within 4 months of stopping therapy. Therefore, the use of prednisolone for tuberculosis in HIV infected patients is not recommended at this time.
Read the detailed description
Recent observations from retrospective cohort studies indicate that HIV-associated tuberculosis (TB) is associated with reduced survival and increased rate of opportunistic infections compared to CD4-matched controls. Mounting evidence from immunologic and virologic studies supports the concept of co-pathogenesis, in which cytokines such as tumor necrosis factor alpha (TNF alpha) are over-expressed during the course of TB and stimulate viral replication in latently infected cells, possibly leading to greater viral load.
Glucocorticoids are potent inhibitors of cytokines, including TNF, and clinicians have extensive experiences with their use in HIV infection. Although corticosteroid use in HIV infection has a record of safety, the safety and bioavailability of corticosteroids in HIV/TB coinfection has not been established.
This study evaluated the change in viral load and CD4 count in HIV infected patients with TB who were treated with oral prednisolone. The study found that the viral load increased slightly when prednisolone was administered and that patients receiving prednisolone cleared their tuberculosis more rapidly. Although there was some benefit to using prednisolone in these patients, the benefit was short-lived and was gone within 4 months of stopping therapy.
- Conditions
- Tuberculosis, HIV Infections
- Being tested
- prednisolone
- Keywords
- Tuberculosis, HIV infection, Prednisolone, Safety, Immune activation
- Medical subject headings
- Tuberculosis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisoloneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2003 (estimated)
- Study startNov 1998
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 190 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Christopher Whalen, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057421
- Sponsor's protocol ID
- R01AI032414
- Other IDs
- R01AI032414
- Status last verified
- Aug 2007
- First submitted
- 1 Apr 2003
- Last updated
- 18 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tuberculosis on HIV Infection in Uganda
- ClinicalTrials.gov ID
- NCT00057421
- Acronym / sponsor ID
- R01AI032414
- Conditions
- Tuberculosis, HIV Infections
- Keywords
- Tuberculosis, HIV infection, Prednisolone, Safety, Immune activation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 1998
- Study completion
- Sep 2002
- First posted
- 3 Apr 2003 (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.
This was a clinical trial in HIV infected patients with tuberculosis. The study assessed whether the addition of prednisolone, a type of steroid medication, to the standard treatment for tuberculosis improved immune and viral outcomes in the patients. The study demonstrated that prednisolone increased the CD4 cell count as was hoped, but the beneficial effect was short-lived and was gone within 4 months of stopping therapy. Therefore, the use of prednisolone for tuberculosis in HIV infected patients is not recommended at this time.
Detailed description
Recent observations from retrospective cohort studies indicate that HIV-associated tuberculosis (TB) is associated with reduced survival and increased rate of opportunistic infections compared to CD4-matched controls. Mounting evidence from immunologic and virologic studies supports the concept of co-pathogenesis, in which cytokines such as tumor necrosis factor alpha (TNF alpha) are over-expressed during the course of TB and stimulate viral replication in latently infected cells, possibly leading to greater viral load.
Glucocorticoids are potent inhibitors of cytokines, including TNF, and clinicians have extensive experiences with their use in HIV infection. Although corticosteroid use in HIV infection has a record of safety, the safety and bioavailability of corticosteroids in HIV/TB coinfection has not been established.
This study evaluated the change in viral load and CD4 count in HIV infected patients with TB who were treated with oral prednisolone. The study found that the viral load increased slightly when prednisolone was administered and that patients receiving prednisolone cleared their tuberculosis more rapidly. Although there was some benefit to using prednisolone in these patients, the benefit was short-lived and was gone within 4 months of stopping therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pulmonary TB (smear positive)
- HIV infected
- Residence within 20 km of Kampala city
- Allows frequent blood specimens to be drawn
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| prednisolone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2007.
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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.
Christopher Whalen principal investigator
Case Western Reserve University
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 prednisolone in people with Tuberculosis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Uganda.
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 4 inclusion and 0 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 18 Sep 2007. 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 Uganda. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 18 Sep 2007.