Mycobacterium Avium-Intracellulare InfectionPhase 2NCT00002192
Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.
A Phase 2 study testing Rifapentine, Ethambutol hydrochloride and Clarithromycin in people with Mycobacterium Avium-Intracellulare Infection and HIV Infections, run by Anderson Clinical Research at 1 site in United States.
Trial summary
To determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC) bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite, 25-desacetyl, alone and in combination therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium Avium-Intracellulare Infection, HIV Infections
- What is being tested?
- Rifapentine, Ethambutol hydrochloride and Clarithromycin
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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
- Patients must have:
- Documented positive HIV serology status.
- Documented AIDS.
- Positive blood culture for MAC from the study-designated microbiology laboratory. NOTE:
- Patients with presumed MAC bacteremia, as evidenced by positive blood, bone marrow, or liver biopsy culture analyzed locally, may be enrolled pending confirmation.
- Minimum of two MAC-associated symptoms, defined as >= grade 1 fever; > grade 1 night sweats, fatigue, diarrhea, abdominal pain, or anorexia; or weight loss > 5% reported within 4 weeks prior to study entry.
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- Life expectancy of at least 3 months.
- Prior Medication:
- Allowed:
- MAC prophylaxis with medications other than study drugs (5-day washout period required).
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Pulmonary tuberculosis.
- Infections requiring the use of disallowed medications.
- Serious diseases that introduce undue risks for adverse reactions to study medication.
- Concurrent Medication:
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- Excluded:
- Terfenadine.
- Treatment for pulmonary TB.
- Study drugs from an outside source.
- Medications with anti-MAC activity (i.e., amikacin, ciprofloxacin, clofazimine, rifampin, and rifabutin).
- Patients with the following prior conditions are excluded:
- History of hypersensitivity to rifabutin, rifampin, clarithromycin, erythromycin, azithromycin, or ethambutol.
- Previous episode of uveitis.
- Prior Medication:
- Excluded:
- Prophylactic treatment for MAC with rifabutin or any of the study medications.
- Azithromycin within the 3 weeks prior to randomization.
- Any investigational drug during the 4 weeks prior to randomization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hampton Roads Med Specialists
Hampton, Virginia, 23666
About this study
To determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC) bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite, 25-desacetyl, alone and in combination therapy. To determine the pharmacokinetics of azithromycin and clarithromycin (and its 14-OH metabolite) in combination therapy.
Read the detailed description
This open-label, sequential study is conducted in two parts: a monotherapy phase and a combination treatment phase.
In the monotherapy phase sequential 3-patient cohorts receive 1 of 3 doses of rifapentine monotherapy.
In the combination treatment phase, 12 patients each are randomized to one of three arms:
Arm I: Rifapentine (assigned dose level based on monotherapy phase) plus azithromycin.
Arm II: Rifapentine (assigned dose level) plus clarithromycin. Arm III: Rifapentine (assigned dose level) plus ethambutol.
- Being tested
- Rifapentine, Ethambutol hydrochloride, Clarithromycin, Azithromycin
- Keywords
- AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Antitubercular Agents, Azithromycin, Clarithromycin, Bacteremia, rifapentine
- Medical subject headings
- Mycobacterium avium-intracellulare Infection, HIV Infections, AIDS-Related Opportunistic Infections, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifapentineDrug
Ethambutol hydrochlorideDrug
ClarithromycinDrug
AzithromycinDrug
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.
- Other trials for Mycobacterium Avium-Intracellulare InfectionStudies 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Anderson Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoechst Marion Roussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002192
- Sponsor's protocol ID
- 275A
- Other IDs
- 000473PR0018, 96ACR-HMD1
- Status last verified
- Aug 1997
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.
- ClinicalTrials.gov ID
- NCT00002192
- Acronym / sponsor ID
- 275A
- Keywords
- AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Antitubercular Agents, Azithromycin, Clarithromycin, Bacteremia, rifapentine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Anderson Clinical ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Hoechst Marion Roussel
- 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 determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC) bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite, 25-desacetyl, alone and in combination therapy. To determine the pharmacokinetics of azithromycin and clarithromycin (and its 14-OH metabolite) in combination therapy.
Detailed description
This open-label, sequential study is conducted in two parts: a monotherapy phase and a combination treatment phase.
In the monotherapy phase sequential 3-patient cohorts receive 1 of 3 doses of rifapentine monotherapy.
In the combination treatment phase, 12 patients each are randomized to one of three arms:
Arm I: Rifapentine (assigned dose level based on monotherapy phase) plus azithromycin.
Arm II: Rifapentine (assigned dose level) plus clarithromycin. Arm III: Rifapentine (assigned dose level) plus ethambutol.
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 (10 listed)
- Documented positive HIV serology status.
- Documented AIDS.
- Positive blood culture for MAC from the study-designated microbiology laboratory. NOTE:
- Patients with presumed MAC bacteremia, as evidenced by positive blood, bone marrow, or liver biopsy culture analyzed locally, may be enrolled pending confirmation.
- Minimum of two MAC-associated symptoms, defined as >= grade 1 fever; > grade 1 night sweats, fatigue, diarrhea, abdominal pain, or anorexia; or weight loss > 5% reported within 4 weeks prior to study entry.
Key exclusion criteria (19 listed)
- Pulmonary tuberculosis.
- Infections requiring the use of disallowed medications.
- Serious diseases that introduce undue risks for adverse reactions to study medication.
- Terfenadine.
- Treatment for pulmonary TB.
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 |
|---|---|---|
| Rifapentine | Drug | – |
| Ethambutol hydrochloride | Drug | – |
| Clarithromycin | Drug | – |
| Azithromycin | 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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rifapentine, Ethambutol hydrochloride and Clarithromycin in people with Mycobacterium Avium-Intracellulare Infection and HIV Infections, run by Anderson Clinical Research at 1 site 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 10 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 24 Jun 2005. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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 Jun 2005.