HIV InfectionsNCT00000638
Preventive Treatment 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 76 sites in 2 countries.
Trial summary
To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. 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
- 76 sitesin 2 countries
- Study dates
- Start not givento Sep 1999
- 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.
- Patients must have:
Show all 11Show fewer
- HIV infection.
- Current or documented history of positive PPD skin test.
- Life expectancy of at least 6 months or, in the physician's opinion, patient has a reasonable chance of survival to end of study.
- 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.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Current active clinical tuberculosis, confirmed or suspected.
- History of sensitivity / intolerance to any study medication.
- Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse.
- Unwilling or unable to have current therapy and/or concomitant medication changed to avoid serious interaction with study medication.
Show all 19Show fewer
- Acute hepatitis.
- Unable to comply with the follow-up requirements of the protocol.
- Concurrent Medication:
- Excluded:
- Treatment with quinolones, fluoroquinolones, aminoglycosides, or other agents that have activity against Mycobacterium tuberculosis.
- Excluded as ongoing (i.e., continuous, chronic and/or recurring) treatment:
- Aminoglycosides such as amikacin, aminosalicylic acid salts (PAS), capreomycin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid (INH) if randomized to rifampin/pyrazinamide arm of study, kanamycin, pyrazinamide if randomized to INH arm of study, and quinolones and fluoroquinolones, i.e., rifabutin, rifampin (if randomized to INH arm of study), ciprofloxacin, levofloxacin, ofloxacin, streptomycin, and thiacetazone.
- Prior Medication:
- Excluded:
- More than 2 months of continuous treatment, after documentation of a positive PPD skin test, with agents that have known or potential antituberculous activity or any antimycobacterial medication for > 1 month.
- Patients may not have the following prior conditions:
- History of sensitivity / intolerance to any study medication.
- Unwilling or unable to comply with the follow-up requirements of the protocol.
Trial locations and contacts
76 sites in 2 countries.
76 sites in 2 countries
United States75 sites
Adirondack Med Ctr at Saranac Lake
Albany, New York, 122083479
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479
Mid - Hudson Care Ctr
Albany, New York, 122083479
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
Interfaith Med Ctr
Brooklyn, New York, 112032098
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Med Univ of South Carolina / UNC
Charleston, South Carolina, 29425
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
Chicago, Illinois, 60611
Northwestern Univ Med School
Chicago, Illinois, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
Univ of Cincinnati
Cincinnati, Ohio, 452670405
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267
Case Western Reserve Univ
Cleveland, Ohio, 44106
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Nassau County Med Ctr
East Meadow, New York, 11554
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
Univ of Texas Galveston
Galveston, Texas, 775550435
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
Queens Med Ctr
Honolulu, Hawaii, 96816
Univ of Hawaii
Honolulu, Hawaii, 96816
Houston Clinical Research Network
Houston, Texas, 77266
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Children's Hosp of Los Angeles
Los Angeles, California, 90027
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
North Shore Univ Hosp
Manhasset, New York, 11030
Univ of Miami School of Medicine
Miami, Florida, 331361013
Meharry Med College
Nashville, Tennessee, 37203
Yale Univ / New Haven
New Haven, Connecticut, 065102483
Beth Israel Med Ctr
New York, New York, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Saint Clare's Hosp and Health Ctr
New York, New York, 10019
Cornell Univ Med Ctr
New York, New York, 10021
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025
Mount Sinai Med Ctr
New York, New York, 10029
Columbia Presbyterian Med Ctr
New York, New York, 100323784
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
Girard Med Ctr
Philadelphia, Pennsylvania, 191046073
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
Wake County Dept of Health
Raleigh, North Carolina, 27610
San Francisco Gen Hosp
San Francisco, California, 941102859
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
Stanford Univ Med Ctr
Stanford, California, 943055107
SUNY - Stony Brook
Stony Brook, New York, 117948153
Olive View Med Ctr
Sylmar, California, 91342
SUNY / State Univ of New York
Syracuse, New York, 13210
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461
Comprehensive Health Care Ctr / Bronx Municipal Hosp
The Bronx, New York, 10461
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
The Bronx, New York, 10461
Montefiore Family Health Ctr / Bronx Municipal Hosp
The Bronx, New York, 10461
Samaritan Village Inc / Bronx Municipal Hosp
The Bronx, New York, 10461
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, 10465
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, 10467
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467
North Central Bronx Hosp / Bronx Municipal Hosp
The Bronx, New York, 10467
Harbor UCLA Med Ctr
Torrance, California, 90502
HIV Ctr - District of Columbia Gen Hosp
Washington D.C., District of Columbia, 200072197
Whitman - Walker Clinic / Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 200072197
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Howard Univ
Washington D.C., District of Columbia, 20059
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
Official title: Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis.
Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
Read the detailed description
Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
Patients are chosen by a random selection process to either the INH or the rifampin / pyrazinamide arm of the dose. Patients on the INH arm receive INH plus vitamin B6 (pyridoxine hydrochloride ) daily for 12 months. Patients on the other arm receive rifampin plus pyrazinamide for 60 days. Dosage of rifampin and pyrazinamide depends on weight of patient.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- Isoniazid, Pyrazinamide, Pyridoxine hydrochloride, Rifampin
- Keywords
- Tuberculosis, Isoniazid, Mycobacterium tuberculosis, 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 completionSep 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prevention
- Intervention model
- Parallel groups
- Enrolment
- 2,000 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Hoechst Marion Roussel, Lederle Laboratories
- Responsible party
- Sponsor
- Investigators
- Chaisson R, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000638
- Sponsor's protocol ID
- ACTG 177
- Other IDs
- CPCRA 004, TB/PPD+, 11152
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 2 Nov 2021
- Results posted
- No
Publications
Halsey N, et al. Twice weekly INH vs RIF and PZA for TB prophylaxis in HIV infected adults. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:55
Gordin 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
- NCT00000638
- Acronym / sponsor ID
- ACTG 177
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- Tuberculosis, Isoniazid, Mycobacterium tuberculosis, Pyrazinamide, Pyridoxine, Rifampin, AIDS-Related Opportunistic Infections, Drug Therapy, Combination
- 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
- Collaborators
- Hoechst Marion Roussel, Lederle Laboratories
- Study completion
- Sep 1999 (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 safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis.
Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
Detailed description
Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
Patients are chosen by a random selection process to either the INH or the rifampin / pyrazinamide arm of the dose. Patients on the INH arm receive INH plus vitamin B6 (pyridoxine hydrochloride ) daily for 12 months. Patients on the other arm receive rifampin plus pyrazinamide for 60 days. Dosage of rifampin and pyrazinamide depends on weight of patient.
Study design
- Primary purpose
- Prevention
- 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 (11 listed)
- Antiretroviral treatment.
- Pneumocystis carinii pneumonia prophylaxis.
- Treatment for acute opportunistic infection.
- HIV infection.
- Current or documented history of positive PPD skin test.
Key exclusion criteria (19 listed)
- Current active clinical tuberculosis, confirmed or suspected.
- History of sensitivity / intolerance to any study medication.
- Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse.
- Unwilling or unable to have current therapy and/or concomitant medication changed to avoid serious interaction with study medication.
- Acute hepatitis.
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.
- BackgroundHalsey N, et al. Twice weekly INH vs RIF and PZA for TB prophylaxis in HIV infected adults. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:55
- 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.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Chaisson R study chair
76 sites in 2 countries: 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 76 sites in 2 countries.
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 11 inclusion and 19 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 76 sites in United States, Puerto Rico. 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 NCT00000638, which also lists 2 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.