HIV InfectionsNCT00000950
Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis
A study testing Ethambutol hydrochloride, Isoniazid and Pyrazinamide in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in United States.
Trial summary
The purpose of this study is to determine if a relationship exists between the level of antituberculosis drugs (isoniazid, rifampin, ethambutol, and pyrazinamide) in the blood and the outcome of HIV-positive patients with tuberculosis. This study also evaluates how these drugs are absorbed and metabolized in the body. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Tuberculosis
- What is being tested?
- Ethambutol hydrochloride, Isoniazid and Pyrazinamide
- How many people
- 50 participants
- Where
- 13 sitesUnited States
- Study dates
- Start not givento May 2002
- Phase
- Interventional
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are HIV-positive and have tuberculosis.
- Are 13 years of age or older.
- Have written, informed consent of parent or guardian if you are under 18 years of age.
- Agree to practice abstinence or use barrier methods of birth control during the study.
Who cannot join
- You will not be eligible for this study if you:
- Have any other disorder or condition which might cause study treatment to be undesirable.
- Are pregnant.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Emory Univ
Atlanta, Georgia, 30308
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
Queens Med Ctr
Honolulu, Hawaii, 96816
Univ of Hawaii
Honolulu, Hawaii, 96816
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
University of Miami (Pediatric)
Miami, Florida, 33136
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
Beth Israel Med Ctr
New York, New York, 10003
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York, New York, 10021
Mount Sinai Med Ctr
New York, New York, 10029
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
Harbor UCLA Med Ctr
Torrance, California, 90502
About this study
Official title: Pharmacokinetics of Antituberculosis Agents in HIV-Infected Persons With Tuberculosis
The purpose of this study is to determine if a relationship exists between the level of antituberculosis drugs (isoniazid, rifampin, ethambutol, and pyrazinamide) in the blood and the outcome of HIV-positive patients with tuberculosis. This study also evaluates how these drugs are absorbed and metabolized in the body.
Read the detailed description
Patients receive up to 8 weeks of two or more anti-tuberculosis drugs, of which at least two are isoniazid, rifampin, pyrazinamide, or ethambutol. Blood specimens are collected at 2, 6, and 10 hours after administration of study medication, once between Days 10 and 14 of a phase of daily treatment and once while on an intermittent dose regimen (twice weekly or three times weekly).
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- Ethambutol hydrochloride, Isoniazid, Pyrazinamide, Pyridoxine hydrochloride, Rifampin
- Keywords
- Tuberculosis, Isoniazid, Pyrazinamide, Pyridoxine, Rifampin, AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Antitubercular Agents
- Medical subject headings
- HIV Infections, Tuberculosis, 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.
Ethambutol hydrochlorideDrug
IsoniazidDrug
PyrazinamideDrug
Pyridoxine hydrochlorideDrug
RifampinDrug
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)
- Primary completionMay 2002
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 N/A
- Primary purpose
- Treatment
- Enrolment
- 50 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Keith Chirgwin, Study chairDavid Perlman, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000950
- Sponsor's protocol ID
- ACTG 309
- Status last verified
- Mar 2011
- First submitted
- 2 Nov 1999
- Last updated
- 2 Mar 2011
- Results posted
- No
Publications
Perlman DC, Segal Y, Rosenkranz S, Rainey PM, Peloquin CA, Remmel RP, Chirgwin K, Salomon N, Hafner R; ACTG 309 Team. The clinical pharmacokinetics of pyrazinamide in HIV-infected persons with tuberculosis. Clin Infect Dis. 2004 Feb 15;38(4):556-64. doi: 10.1086/381096. Epub 2004 Jan 28.
PubMed 14765350
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Antituberculosis Agents in HIV-Infected Persons With Tuberculosis
- ClinicalTrials.gov ID
- NCT00000950
- Acronym / sponsor ID
- ACTG 309
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- Tuberculosis, Isoniazid, Pyrazinamide, Pyridoxine, Rifampin, AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Ethambutol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Primary completion
- May 2002 (actual)
- 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.
The purpose of this study is to determine if a relationship exists between the level of antituberculosis drugs (isoniazid, rifampin, ethambutol, and pyrazinamide) in the blood and the outcome of HIV-positive patients with tuberculosis. This study also evaluates how these drugs are absorbed and metabolized in the body.
Detailed description
Patients receive up to 8 weeks of two or more anti-tuberculosis drugs, of which at least two are isoniazid, rifampin, pyrazinamide, or ethambutol. Blood specimens are collected at 2, 6, and 10 hours after administration of study medication, once between Days 10 and 14 of a phase of daily treatment and once while on an intermittent dose regimen (twice weekly or three times weekly).
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Are HIV-positive and have tuberculosis.
- Are 13 years of age or older.
- Have written, informed consent of parent or guardian if you are under 18 years of age.
- Agree to practice abstinence or use barrier methods of birth control during the study.
Key exclusion criteria (3 listed)
- Have any other disorder or condition which might cause study treatment to be undesirable.
- Are pregnant.
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 |
|---|---|---|
| Ethambutol hydrochloride | Drug | – |
| Isoniazid | Drug | – |
| Pyrazinamide | Drug | – |
| Pyridoxine hydrochloride | Drug | – |
| Rifampin | 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 2 Mar 2011.
- Background: PubMed 14765350Perlman DC, Segal Y, Rosenkranz S, Rainey PM, Peloquin CA, Remmel RP, Chirgwin K, Salomon N, Hafner R; ACTG 309 Team. The clinical pharmacokinetics of pyrazinamide in HIV-infected persons with tuberculosis. Clin Infect Dis. 2004 Feb 15;38(4):556-64. doi: 10.1086/381096. Epub 2004 Jan 28.
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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.
Keith Chirgwin study chair
David Perlman study chair
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethambutol hydrochloride, Isoniazid and Pyrazinamide in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 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 5 inclusion and 3 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 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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.
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 NCT00000950, 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 2 Mar 2011.