HIV InfectionsNCT00000636
Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
A study testing Isoniazid, Pyrazinamide and Pyridoxine hydrochloride in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 25 sites in United States.
Trial summary
To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb). 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?
- Isoniazid, Pyrazinamide and Pyridoxine hydrochloride
- How many people
- 2,000 participants
- Where
- 25 sitesUnited States
- Study dates
- Start not givento Oct 1997
- 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
- Concurrent Medication:
- Allowed:
- Antiretroviral treatment.
- Pneumocystis carinii pneumonia prophylaxis.
- Treatment for acute opportunistic infection/malignancy.
- Aminoglycosides, quinolones or fluoroquinolones such as ciprofloxacin or ofloxacin for < 14 days for treatment of intercurrent infection.
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- Patients must have:
- HIV infection.
- Signed informed consent.
- Reasonably good health at time of study entry.
- Perceived life expectancy of at least six months.
- Allowed:
- Participation in other clinical trials as long as there is no potential activity of other study drugs against Mycobacterium tuberculosis (MTb), additive toxicities between study agents, or known possible drug interactions between study drugs.
- Prior Medication:
- Allowed:
- Treatment with quinolones, fluoroquinolones, aminoglycosides, or other agents with known or potential activity against M. tuberculosis.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Current active tuberculosis (confirmed or suspected).
- Sensitivity or intolerance to study medication.
- Acute hepatitis.
- Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse.
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- Inability to have concomitant medications changed to avoid serious interaction with study drug.
- Concurrent Medication:
- Excluded:
- -
- Quinolones, fluoroquinolones, or aminoglycosides with antituberculous activity (may be used for up to 14 days for treatment of intercurrent infection).Other agents with known or potential antituberculous activity should be avoided, including the following:
- Aminosalicylic acid salts, capreomycin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin, pyrazinamide, rifabutin, rifampin, streptomycin, and thiacetazone.
- Prior Medication:
- Excluded:
- History of treatment for > 2 months with agents that have known or potential antituberculous activity other than those specifically allowed.
- Agents with potential or known antituberculous activity include the following:
- Aminoglycosides such as amikacin, aminosalicylic acid salts, capreomycin, ciprofloxacin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin, ofloxacin, pyrazinamide, quinolones or fluoroquinolones, rifabutin, rifampin, streptomycin, and thiacetazone.
- Patients may not have:
- Current active tuberculosis.
- Acute hepatitis.
- Peripheral neuropathy of grade 3 or grade 4.
- Willing and able, in the clinician's opinion, to comply with the treatment and clinical management issues.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Johns Hopkins Univ / Brazil
Baltimore, Maryland, 21205
Johns Hopkins Univ / School of Hygiene & Public Health
Baltimore, Maryland, 21205
Boston Dept of Health and Hosps
Boston, Massachusetts, 02118
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103
Chicago Dept of Health / Speciality STD Clinic
Chicago, Illinois, 60605
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201
Henry Ford Hosp
Detroit, Michigan, 48202
Hill Health Corp
New Haven, Connecticut, 06519
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
Clinical Directors Network of Region II
New York, New York, 10011
Beth Israel Med Ctr
New York, New York, 10035
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037
Saint Michael's Med Ctr
Newark, New Jersey, 07102
Lattimore Comprehensive Pulmonary Disease Clinic
Newark, New Jersey, 07103
North Jersey Community Research Initiative
Newark, New Jersey, 07103
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Richmond AIDS Consortium
Richmond, Virginia, 23298
Community Consortium / UCSF
San Francisco, California, 94110
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10456
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899
About this study
To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb).
Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.
Read the detailed description
Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.
After baseline screening, patients are randomized to one of two treatment arms and are evaluated by means of clinic visits monthly for the first three months, then every three months for the first year (there are additional clinic visits for INH patients). Patients are then evaluated every six months. One group of patients takes INH plus vitamin B6 for 12 months. The other group of patients takes 1 of 2 doses of rifampin (depending on patient's weight) plus pyrazinamide in 3-4 divided doses for 60 days.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- Isoniazid, Pyrazinamide, Pyridoxine hydrochloride, Rifampin
- Keywords
- Tuberculosis, Isoniazid, Pyrazinamide, Pyridoxine, Rifampin, AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antitubercular Agents, AIDS-Related Complex
- Medical subject headings
- HIV Infections, Tuberculosis, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
- Study completionOct 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Intervention model
- Parallel groups
- Enrolment
- 2,000 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gordin F, Study chairBrown LS, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000636
- Sponsor's protocol ID
- CPCRA 004
- Other IDs
- TB/PPD+, ACTG 177, 11556
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 2 Nov 2021
- Results posted
- No
Publications
Gordin F, Matts J, Miller C, Chaisson R, Garcia M, O'Brien R. Risk factors for developing active tuberculosis (TB) among HIV-infected, PPD-positive (+) patients (pts). Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:151 (abstract no 448)
New TB guidelines for persons with HIV. AIDS Treat News. 1998 Nov 6;(No 306):6.
PubMed 11365963Gordin F, Chaisson RE, Matts JP, Miller C, de Lourdes Garcia M, Hafner R, Valdespino JL, Coberly J, Schechter M, Klukowicz AJ, Barry MA, O'Brien RJ. Rifampin and pyrazinamide vs isoniazid for prevention of tuberculosis in HIV-infected persons: an international randomized trial. Terry Beirn Community Programs for Clinical Research on AIDS, the Adult AIDS Clinical Trials Group, the Pan American Health Organization, and the Centers for Disease Control and Prevention Study Group. JAMA. 2000 Mar 15;283(11):1445-50. doi: 10.1001/jama.283.11.1445.
PubMed 10732934
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
- ClinicalTrials.gov ID
- NCT00000636
- Acronym / sponsor ID
- CPCRA 004
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- Tuberculosis, Isoniazid, Pyrazinamide, Pyridoxine, Rifampin, AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Oct 1997 (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.
To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb).
Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.
Detailed description
Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.
After baseline screening, patients are randomized to one of two treatment arms and are evaluated by means of clinic visits monthly for the first three months, then every three months for the first year (there are additional clinic visits for INH patients). Patients are then evaluated every six months. One group of patients takes INH plus vitamin B6 for 12 months. The other group of patients takes 1 of 2 doses of rifampin (depending on patient's weight) plus pyrazinamide in 3-4 divided doses for 60 days.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Antiretroviral treatment.
- Pneumocystis carinii pneumonia prophylaxis.
- Treatment for acute opportunistic infection/malignancy.
- Aminoglycosides, quinolones or fluoroquinolones such as ciprofloxacin or ofloxacin for < 14 days for treatment of intercurrent infection.
- HIV infection.
Key exclusion criteria (22 listed)
- Current active tuberculosis (confirmed or suspected).
- Sensitivity or intolerance to study medication.
- Acute hepatitis.
- Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse.
- Inability to have concomitant medications changed to avoid serious interaction with study drug.
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 | – |
| 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 Nov 2021.
- BackgroundGordin F, Matts J, Miller C, Chaisson R, Garcia M, O'Brien R. Risk factors for developing active tuberculosis (TB) among HIV-infected, PPD-positive (+) patients (pts). Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:151 (abstract no 448)
- Background: PubMed 11365963New TB guidelines for persons with HIV. AIDS Treat News. 1998 Nov 6;(No 306):6.
- Background: PubMed 10732934Gordin F, Chaisson RE, Matts JP, Miller C, de Lourdes Garcia M, Hafner R, Valdespino JL, Coberly J, Schechter M, Klukowicz AJ, Barry MA, O'Brien RJ. Rifampin and pyrazinamide vs isoniazid for prevention of tuberculosis in HIV-infected persons: an international randomized trial. Terry Beirn Community Programs for Clinical Research on AIDS, the Adult AIDS Clinical Trials Group, the Pan American Health Organization, and the Centers for Disease Control and Prevention Study Group. JAMA. 2000 Mar 15;283(11):1445-50. doi: 10.1001/jama.283.11.1445.
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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.
Gordin F study chair
Brown LS study chair
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoniazid, Pyrazinamide and Pyridoxine hydrochloride in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 25 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 16 inclusion and 22 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 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 NCT00000636, which also lists 3 linked publications.
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 Nov 2021.