HIV InfectionsPhase 4NCT00023400
TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB
A Phase 4 study testing Nelfinavir and Rifabutin in people with HIV Infections and Tuberculosis, run by Centers for Disease Control and Prevention at 23 sites in 2 countries.
Trial summary
Primary Objective: To define the impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on peak levels and area under the curve for rifabutin and the rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as part of tuberculosis chemotherapy. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- HIV Infections, Tuberculosis
- What is being tested?
- Nelfinavir and Rifabutin
- How many people
- 20 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Feb 2000to Feb 2002
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Patients with HIV-related tuberculosis
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States20 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287-0003
Boston Medical Center
Boston, Massachusetts, 02118
Carolinas Medical Center
Charlotte, North Carolina, 28203
Chicago VA Medical Center (Lakeside)
Chicago, Illinois, 60611
Denver Department of Public Health and Hospitals
Denver, Colorado, 80204
Duke University Medical Center
Durham, North Carolina, 34222
University of North Texas Health Science Center
Fort Worth, Texas, 76107-2699
Hines VA Medical Center
Hines, Illinois, 60141
Thomas Street Clinic
Houston, Texas, 77009
Central Arkansas Veterans Health System
Little Rock, Arkansas, 72205
LA County/USC Medical Center
Los Angeles, California, 90033
Nashville VA Medical Center
Nashville, Tennessee, 37212-2637
New York University School of Medicine
New York, New York, 10016
Columbia University/Presbyterian Medical Center
New York, New York, 10032
Harlem Hospital Center
New York, New York, 10037
New Jersey Medical School
Newark, New Jersey, 07107-3001
Audi L. Murphy VA Hospital
San Antonio, Texas, 78284
University of California, San Francisco
San Francisco, California, 94110
Seattle King County Health Department
Seattle, Washington, 98104
Washington, D.C. VAMC
Washington D.C., District of Columbia, 20422
Canada3 sites
Montreal Chest Institute McGill University
Montreal, Quebec, H2X 2P4Pq Canada
University of British Columbia
Vancouver, British Columbia, Canada V5Z 4R4
University of Manitoba
Winnipeg, Manitoba, CANADA R3A 1R8
About this study
Official title: TBTC Study 23B:Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen
Primary Objective:
To define the impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on peak levels and area under the curve for rifabutin and the rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as part of tuberculosis chemotherapy.
Read more
Secondary Objectives:
To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin.
To evaluate the correlation between pharmacokinetic parameters of rifabutin and 25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients with HIV-related tuberculosis.
To define detailed pharmacokinetics of isoniazid given at 15mg/kg or 900 mg in patients with HIV-related tuberculosis.
To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic studies.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- Nelfinavir, Rifabutin
- Keywords
- tuberculosis, TB
- Medical subject headings
- HIV Infections, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NelfinavirDrug
RifabutinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on area under the curve for rifabutin and 25-O-desacetyl rifabutin when rifabutin is given 300 mg bi-weekly as part of tuberculosis chemotherapy.
Secondary outcomes (1)
To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2001 (estimated)
- Study startFeb 2000
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Investigators
- Debra Benator, MD, Study chair, Washington, D.C. VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023400
- Sponsor's protocol ID
- CDC-NCHSTP-2587
- Other IDs
- 23B
- Status last verified
- Sep 2005
- First submitted
- 6 Sep 2001
- Last updated
- 5 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TBTC Study 23B:Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen
- ClinicalTrials.gov ID
- NCT00023400
- Acronym / sponsor ID
- CDC-NCHSTP-2587
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- tuberculosis, TB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- Feb 2000
- Study completion
- Feb 2002
- First posted
- 10 Sep 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.
Primary Objective:
To define the impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on peak levels and area under the curve for rifabutin and the rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as part of tuberculosis chemotherapy.
Secondary Objectives:
To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin.
To evaluate the correlation between pharmacokinetic parameters of rifabutin and 25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients with HIV-related tuberculosis.
To define detailed pharmacokinetics of isoniazid given at 15mg/kg or 900 mg in patients with HIV-related tuberculosis.
To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Nelfinavir | Drug | – |
| Rifabutin | Drug | – |
Primary outcome
Impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on area under the curve for rifabutin and 25-O-desacetyl rifabutin when rifabutin is given 300 mg bi-weekly as part of tuberculosis chemotherapy.
1 secondary outcome
To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin.
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 5 Sep 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.
Debra Benator, MD study chair
Washington, D.C. VAMC
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nelfinavir and Rifabutin in people with HIV Infections and Tuberculosis, run by Centers for Disease Control and Prevention at 23 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?
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 5 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. 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?
Impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on area under the curve for rifabutin and 25-O-desacetyl rifabutin when rifabutin is given 300 mg bi-weekly as part of tuberculosis chemotherapy.. It is what the study was designed to measure, not a finding.
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 5 Sep 2005.