HIV InfectionsPhase 4NCT00402610
A Randomized Trial of Three Regimens to Prevent Tuberculosis in HIV-Infected Patients With Anergy
A Phase 4 study testing isoniazid, rifampin + isoniazid, rifampin + pyrazinamide or not treatment in people with HIV Infections and Tuberculosis, run by Sociedad Andaluza de Enfermedades Infecciosas at 1 site in Spain.
Trial summary
INTRODUCTION. To evaluate the efficacy of three regimens of prophylactic therapy for tuberculosis in HIV-infected patients with anergy. METHODS. Prospective, multi-center, randomized, comparative, and open clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections, Tuberculosis
- What is being tested?
- isoniazid, rifampin + isoniazid, rifampin + pyrazinamide or not treatment
- How many people
- 332 participants
- Where
- 1 siteSpain
- Study dates
- Jan 1994to Dec 1998
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infection confirmed by ELISA and Western blot
- Age between 18 and 65 years
- Life expectancy greater than two years
- Cutaneous anergy defined by the absence of a reaction (0 mm) to skin reactivity tests with tuberculin, Candida albicans, and parotiditis antigens 72 hours after inoculation.
Who cannot join
- Presence of active tuberculosis
- Background of previous antituberculosis therapy or chemoprophylaxis
- Presence of symptoms or signs suggesting pulmonary or extra-pulmonary tuberculosis
- History of hypersensitivity to the drugs used in the study (isoniazid, rifampin or pyrazinamide)
- Aspartate-aminotransferase and/or alanine-aminotransferase plasma concentrations more than or equal to four times their normal values, total bilirubin more than 2 mg/ml, and/or creatinine more than 2 mg/ml
- Pregnancy
- Undergoing treatment incompatible with any of the drugs used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
INTRODUCTION. To evaluate the efficacy of three regimens of prophylactic therapy for tuberculosis in HIV-infected patients with anergy. METHODS. Prospective, multi-center, randomized, comparative, and open clinical trial. Anergy was defined as absence of induration in response to three antigens (PPD, Candida albicans and parotiditis antigen) applied by the Mantoux method. Patients were randomized into one of the following prophylactic treatment groups: isoniazid for six months (6H), rifampin plus isoniazid for three months (3RH), rifampin plus pyrazinamide for two months (2RZ) or no treatment (NT). After completion of treatment, patients were followed up for two years.
Read the detailed description
This study is a controlled, open, randomized, multi-center clinical trial. The study was authorized by the Clinical Research Ethics Committee of all participating centers and informed written consent was obtained from all the patients included. The cutaneous anergy was defined by the absence of a reaction (0 mm) to skin reactivity tests with tuberculin, Candida albicans, and parotiditis antigens 72 hours after inoculation. The patients were randomzed into one of the following four groups: isoniazid for 6 months (6H), rifampin plus isoniazid for 3 months (3RH), rifampin plus pyrazinamide for 2 months (2RZ) or no treatment (NT). All of the participating subjects underwent a basal study that included clinical and epidemiological history, chest x-ray, hemogram, analysis of serum creatinine concentrations, uric acid, AST, ALT, alkaline phosphatase, and total bilirubin, as well as a CD4+ T-lymphocyte count.During prophylactic treatment, patients were evaluated every 15 days for the first two months and monthly thereafter. At each check-up it was determined whether or not the patient was following the treatment properly and whether there were any adverse effects. Therapeutic completion was defined as taking at least 80% of the total prescribed dosages.Chemoprophylaxis was discontinued whenever a patient requested to do so or for any of the following reasons: appearance of Grade 3 or 4 side effects that could be attributed to the drugs used in the study; increases in AST and/or ALT values of three times or more their basal values; development of TB; or diagnosis of any disease that made interruption of the treatment advisable.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- isoniazid, rifampin + isoniazid, rifampin + pyrazinamide or not treatment
- Keywords
- HIV, Tuberculosis, Chemoprophylaxis, Anergy, AIDS
- Medical subject headings
- HIV Infections, Tuberculosis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isoniazid, rifampin + isoniazid, rifampin + pyrazinamide or not treatmentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of tuberculosis
Secondary outcomes (2)
Suspension of chemoprophylaxis due to adverse effects
Mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startJan 1994
- Study completionDec 1998
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.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants
Sponsor and investigators
- Lead sponsor
- Sociedad Andaluza de Enfermedades Infecciosas
- Sponsor type
- Research network
- Investigators
- Antonio Rivero, MD PhD, Study chair, Hospital Universitario Reina Sofía, Córdoba, SpainLuis Lopez-Crtés, MD, PhD, Principal investigator, Hospital Universitario Virgen del Rocío, Sevilla, SpainRafael Castillo, MD, Principal investigator, 3 Sección de Enfermedades Infecciosas. Hospital Clínico Universitario San Cecilio. Avda. Dr. Oloriz 16. 18012 GranadaJosé Verdejo, MD, Principal investigator, Servicio de Enfermedades Infecciosas. Hospital Carlos III. Sinesio Delgado 10. 28029 MadridMiguel Angel García, MD, Principal investigator, Sección de Enfermedades Infecciosas. Hospital Carlos Haya. Avda. Carlos Haya s/n. 29010 Málaga.Felipes Diez, MD, Principal investigator, Servicio de Medicina Interna. Hospital Torrecárdenas. Paraje de Torrecárdenas s/n. 04009 Almería.Jose Carlos Escribano, MD, Principal investigator, Sección de Enfermedades Infecciosas. Hospital Universitario Puerta del Mar. Avda. Ana de Viya, 21. 11009 Cádiz. SpainJesús Canueto, MD, Principal investigator, Sección de Enfermedades Infecciosas. Hospital Punta Europa de Algeciras. Ctra de Getares s/n. 11207 Algeciras (Cádiz)., Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402610
- Sponsor's protocol ID
- GAEI 94/0071a
- Other IDs
- FIS 94/0071A
- Status last verified
- Nov 2006
- First submitted
- 18 Nov 2006
- Last updated
- 24 Oct 2008
- Results posted
- No
Publications
Rivero A, Lopez-Cortes L, Castillo R, Lozano F, Garcia MA, Diez F, Escribano JC, Canueto J, Pasquau J, Hernandez JJ, Polo R, Martinez-Marcos FJ, Kindelan JM, Rey R; Grupo Andaluz para el estudio de las Enfermedades Infecciosas (GAEI). [Randomized trial of three regimens to prevent tuberculosis in HIV-infected patients with anergy]. Enferm Infecc Microbiol Clin. 2003 Jun-Jul;21(6):287-92. doi: 10.1016/s0213-005x(03)72942-5. Spanish.
PubMed 12809582
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Three Regimens to Prevent Tuberculosis in HIV-Infected Patients With Anergy
- ClinicalTrials.gov ID
- NCT00402610
- Acronym / sponsor ID
- GAEI 94/0071a
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- HIV, Tuberculosis, Chemoprophylaxis, Anergy, AIDS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants
- Lead sponsor
- Sociedad Andaluza de Enfermedades InfecciosasResearch network
- Study start
- Jan 1994
- Study completion
- Dec 1998
- First posted
- 22 Nov 2006 (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.
INTRODUCTION. To evaluate the efficacy of three regimens of prophylactic therapy for tuberculosis in HIV-infected patients with anergy. METHODS. Prospective, multi-center, randomized, comparative, and open clinical trial. Anergy was defined as absence of induration in response to three antigens (PPD, Candida albicans and parotiditis antigen) applied by the Mantoux method. Patients were randomized into one of the following prophylactic treatment groups: isoniazid for six months (6H), rifampin plus isoniazid for three months (3RH), rifampin plus pyrazinamide for two months (2RZ) or no treatment (NT). After completion of treatment, patients were followed up for two years.
Detailed description
This study is a controlled, open, randomized, multi-center clinical trial. The study was authorized by the Clinical Research Ethics Committee of all participating centers and informed written consent was obtained from all the patients included. The cutaneous anergy was defined by the absence of a reaction (0 mm) to skin reactivity tests with tuberculin, Candida albicans, and parotiditis antigens 72 hours after inoculation. The patients were randomzed into one of the following four groups: isoniazid for 6 months (6H), rifampin plus isoniazid for 3 months (3RH), rifampin plus pyrazinamide for 2 months (2RZ) or no treatment (NT). All of the participating subjects underwent a basal study that included clinical and epidemiological history, chest x-ray, hemogram, analysis of serum creatinine concentrations, uric acid, AST, ALT, alkaline phosphatase, and total bilirubin, as well as a CD4+ T-lymphocyte count.During prophylactic treatment, patients were evaluated every 15 days for the first two months and monthly thereafter. At each check-up it was determined whether or not the patient was following the treatment properly and whether there were any adverse effects. Therapeutic completion was defined as taking at least 80% of the total prescribed dosages.Chemoprophylaxis was discontinued whenever a patient requested to do so or for any of the following reasons: appearance of Grade 3 or 4 side effects that could be attributed to the drugs used in the study; increases in AST and/or ALT values of three times or more their basal values; development of TB; or diagnosis of any disease that made interruption of the treatment advisable.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV infection confirmed by ELISA and Western blot
- Age between 18 and 65 years
- Life expectancy greater than two years
- Cutaneous anergy defined by the absence of a reaction (0 mm) to skin reactivity tests with tuberculin, Candida albicans, and parotiditis antigens 72 hours after inoculation.
Key exclusion criteria (7 listed)
- Presence of active tuberculosis
- Background of previous antituberculosis therapy or chemoprophylaxis
- Presence of symptoms or signs suggesting pulmonary or extra-pulmonary tuberculosis
- History of hypersensitivity to the drugs used in the study (isoniazid, rifampin or pyrazinamide)
- Aspartate-aminotransferase and/or alanine-aminotransferase plasma concentrations more than or equal to four times their normal values, total bilirubin more than 2 mg/ml, and/or creatinine more than 2 mg/ml
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, rifampin + isoniazid, rifampin + pyrazinamide or not treatment | Drug | – |
Primary outcome
Development of tuberculosis
2 secondary outcomes
Suspension of chemoprophylaxis due to adverse effects
Mortality
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 24 Oct 2008.
- Results publication: PubMed 12809582Rivero A, Lopez-Cortes L, Castillo R, Lozano F, Garcia MA, Diez F, Escribano JC, Canueto J, Pasquau J, Hernandez JJ, Polo R, Martinez-Marcos FJ, Kindelan JM, Rey R; Grupo Andaluz para el estudio de las Enfermedades Infecciosas (GAEI). [Randomized trial of three regimens to prevent tuberculosis in HIV-infected patients with anergy]. Enferm Infecc Microbiol Clin. 2003 Jun-Jul;21(6):287-92. doi: 10.1016/s0213-005x(03)72942-5. Spanish.
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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.
Antonio Rivero, MD PhD study chair
Hospital Universitario Reina Sofía, Córdoba, Spain
Luis Lopez-Crtés, MD, PhD principal investigator
Hospital Universitario Virgen del Rocío, Sevilla, Spain
Rafael Castillo, MD principal investigator
3 Sección de Enfermedades Infecciosas. Hospital Clínico Universitario San Cecilio. Avda. Dr. Oloriz 16. 18012 Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing isoniazid, rifampin + isoniazid, rifampin + pyrazinamide or not treatment in people with HIV Infections and Tuberculosis, run by Sociedad Andaluza de Enfermedades Infecciosas at 1 site in Spain.
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 7 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 24 Oct 2008. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Development of tuberculosis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00402610, 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 24 Oct 2008.