HIV InfectionsPhase 1NCT00000778
A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin
A Phase 1 study testing Isoniazid, Pyridoxine hydrochloride and Levofloxacin in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
Trial summary
To evaluate the methodology for rapidly determining the early bactericidal activity (EBA), tolerance, and pharmacokinetics of isoniazid and levofloxacin in the treatment of pulmonary tuberculosis (TB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Tuberculosis
- What is being tested?
- Isoniazid, Pyridoxine hydrochloride and Levofloxacin
- How many people
- 44 participants
- Where
- 10 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed in all patients:
- Antacids if administered more than 2 hours before or after study drug.
- Allowed in isoniazid patients:
- Anticonvulsant therapy if blood levels are monitored.
- Allowed in levofloxacin patients:
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- Acceptable medications other than antacids if administered at least 2 hours before or 1 hour after study drug.
- Anticonvulsant therapy, theophylline, or warfarin if doses are monitored.
- Patients must have:
- Presumptive active pulmonary TB.
- No clinical evidence of central nervous system or miliary tuberculosis.
- NOTE:
- Both HIV-positive and HIV-negative patients are eligible.
- NOTE:
- Pregnant women may be enrolled in the isoniazid cohort only.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Active or suspected MAI infection.
- Active or suspected hepatitis.
- Any other serious acute infection, diabetes, chronic obstructive pulmonary disease, malignancy requiring chemotherapy, or major organ dysfunction.
- Extreme illness or toxic appearance.
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- Pregnancy (if entering the levofloxacin portion of the study).
- Concurrent Medication:
- Excluded:
- All standard TB therapies.
- Clofazimine.
- Rifabutin.
- Quinolones.
- Aminoglycosides.
- Corticosteroids.
- Pentoxifylline.
- Colony-stimulating factors.
- Interferons.
- Interleukins.
- Disulfiram (patients receiving isoniazid).
- Patients with the following prior conditions are excluded:
- History of treatment-limiting intolerance or known hypersensitivity to isoniazid (in patients receiving isoniazid) or to quinolones (in patients receiving levofloxacin).
- Vomiting or diarrhea >= grade 2 at screening or within 2 days prior to screening.
- History of drug-resistant TB (in patients receiving isoniazid).
- Prior Medication:
- Excluded:
- Any prior treatment or prophylaxis for TB if enrolling on the isoniazid cohort.
- Any anti-TB drug within the past 12 weeks, including standard drugs against TB as well as clofazimine, rifabutin, and all quinolones and aminoglycosides.
- Corticosteroids, pentoxifylline, colony-stimulating factors, interferons, or interleukins within the past 12 weeks.
- Known risk factors for multi-drug resistant (MDR) TB, including:
- Domicile, shelter, or prison exposure to a known case of MDR TB within the past 6 months.
- Residence in a specific domicile, shelter, or prison cell block within 6 months of a known outbreak of MDR TB.
- Hospitalization, within the past 6 months, on a medical service or unit in which nosocomial transmission of MDR TB is known to have occurred.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Univ of Alabama at Birmingham
Birmingham, Alabama, 352336505
Univ of Illinois
Chicago, Illinois, 60622
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Broward Gen Med Ctr
Fort Lauderdale, Florida, 33316
Univ TX Galveston
Galveston, Texas, 77550
Baylor College of Medicine / Houston Veterans Adm Med Ctr
Houston, Texas, 77030
UCLA Med Ctr
Los Angeles, California, 900951793
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
Tulane Univ Med School
New Orleans, Louisiana, 701122699
Harbor - UCLA Med Ctr
Torrance, California, 90502
About this study
To evaluate the methodology for rapidly determining the early bactericidal activity (EBA), tolerance, and pharmacokinetics of isoniazid and levofloxacin in the treatment of pulmonary tuberculosis (TB).
Traditionally, in trials for treatment of TB, a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time. In this setting, it is difficult to determine the effect of any single drug or dose level. Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period. This study utilizes a method to measure the amount of bacteria present each day in the lungs.
Read the detailed description
Traditionally, in trials for treatment of TB, a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time. In this setting, it is difficult to determine the effect of any single drug or dose level. Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period. This study utilizes a method to measure the amount of bacteria present each day in the lungs.
An initial cohort of patients receive isoniazid (with pyridoxine) daily for 5 days. Sputum samples are collected daily for determination of the EBA (decline in colony-forming units/ml sputum). If the methodology is validated, additional patients are randomized to receive one of two doses of levofloxacin daily for 5 days, with determination of EBA. All patients are hospitalized for 2 days of baseline evaluation and 5 days of treatment.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- Isoniazid, Pyridoxine hydrochloride, Levofloxacin
- Keywords
- Isoniazid, Tuberculosis, Pulmonary, Pyridoxine, Ofloxacin, AIDS-Related Opportunistic Infections, Drug Evaluation, Acquired Immunodeficiency Syndrome, Sputum, Colony Count, Microbial
- Medical subject headings
- HIV Infections, Tuberculosis, Tuberculosis, Pulmonary, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoniazidDrug
Pyridoxine hydrochlorideDrug
LevofloxacinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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 1
- Primary purpose
- Treatment
- Enrolment
- 44 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Hafner R, Study chairCohn J, Study chairEgorin M, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000778
- Sponsor's protocol ID
- DATRI 008
- Status last verified
- Jun 1995
- First submitted
- 2 Nov 1999
- Last updated
- 8 Aug 2008
- Results posted
- No
Publications
El-Sadr WM, Perlman DC, Matts JP, Nelson E, Cohn D, Telzak E, Chirgwin K, Salomon N, Olibrice M, Hafner R. Outcome of an induction regimen for the treatment of HIV-related tuberculosis (TB): evaluation of the addition of a quinolone. Int Conf AIDS. 1996 Jul 7-12;11(1):327 (abstract no TuB2358)
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin
- ClinicalTrials.gov ID
- NCT00000778
- Acronym / sponsor ID
- DATRI 008
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- Isoniazid, Tuberculosis, Pulmonary, Pyridoxine, Ofloxacin, AIDS-Related Opportunistic Infections, Drug Evaluation, Acquired Immunodeficiency Syndrome, Sputum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 31 Aug 2001 (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.
To evaluate the methodology for rapidly determining the early bactericidal activity (EBA), tolerance, and pharmacokinetics of isoniazid and levofloxacin in the treatment of pulmonary tuberculosis (TB).
Traditionally, in trials for treatment of TB, a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time. In this setting, it is difficult to determine the effect of any single drug or dose level. Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period. This study utilizes a method to measure the amount of bacteria present each day in the lungs.
Detailed description
Traditionally, in trials for treatment of TB, a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time. In this setting, it is difficult to determine the effect of any single drug or dose level. Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period. This study utilizes a method to measure the amount of bacteria present each day in the lungs.
An initial cohort of patients receive isoniazid (with pyridoxine) daily for 5 days. Sputum samples are collected daily for determination of the EBA (decline in colony-forming units/ml sputum). If the methodology is validated, additional patients are randomized to receive one of two doses of levofloxacin daily for 5 days, with determination of EBA. All patients are hospitalized for 2 days of baseline evaluation and 5 days of treatment.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Antacids if administered more than 2 hours before or after study drug.
- Anticonvulsant therapy if blood levels are monitored.
- Acceptable medications other than antacids if administered at least 2 hours before or 1 hour after study drug.
- Anticonvulsant therapy, theophylline, or warfarin if doses are monitored.
- Presumptive active pulmonary TB.
Key exclusion criteria (33 listed)
- Active or suspected MAI infection.
- Active or suspected hepatitis.
- Any other serious acute infection, diabetes, chronic obstructive pulmonary disease, malignancy requiring chemotherapy, or major organ dysfunction.
- Extreme illness or toxic appearance.
- Pregnancy (if entering the levofloxacin portion of the study).
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 |
|---|---|---|
| Isoniazid | Drug | – |
| Pyridoxine hydrochloride | Drug | – |
| Levofloxacin | 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 8 Aug 2008.
- BackgroundEl-Sadr WM, Perlman DC, Matts JP, Nelson E, Cohn D, Telzak E, Chirgwin K, Salomon N, Olibrice M, Hafner R. Outcome of an induction regimen for the treatment of HIV-related tuberculosis (TB): evaluation of the addition of a quinolone. Int Conf AIDS. 1996 Jul 7-12;11(1):327 (abstract no TuB2358)
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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.
Hafner R study chair
Cohn J study chair
Egorin M study chair
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Isoniazid, Pyridoxine hydrochloride and Levofloxacin in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
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 15 inclusion and 33 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 8 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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 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.
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?
On the ClinicalTrials.gov record for NCT00000778, which also lists 1 linked publication.
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 8 Aug 2008.