HIV InfectionsPhase 4OPTI-NNRTINCT00523458
A Study to Determine the Best Dose of Antivirals in Patients With Both TB and HIV
A Phase 4 study testing efavirenz or nevirapine in people with HIV Infections and Tuberculosis, run by Stanford University at 1 site in Brazil.
Trial summary
Because drugs used to treat TB can reduce the amount of the anti-HIV drugs that reach the sites where the virus is located, this study is designed to see whether it is necessary to use higher doses of antiviral (anti-HIV) drugs while patients are receiving therapy with rifampin, one of the drugs commonly used to treat… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Tuberculosis
- What is being tested?
- efavirenz or nevirapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2007to Mar 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ARV naïve subjects
- Documented HIV infection
- Documented TB infection
- Platelet count 40,000/mm3
- Hemoglobin ≥8.0 g/dL
- Absolute neutrophil count (ANC) >500/mm3
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- AST (SGOT), ALT (SGPT), and alkaline phosphatase <3 X ULN
- Total bilirubin <2.5 x ULN
- Calculated creatinine clearance ≥60 mL/min
- For women of reproductive potential, negative urine pregnancy test
Who cannot join
- Unable to provide informed consent.
- History drug abuse that the investigators suspect will interfere with compliance to study medications and visits.
- Patients on hemodialysis.
- Tuberculosis meningitis.
- Women with CD4 > 250 and men with CD4 > 400 due to higher risk of hepatotoxicity related to use of NVP.
- Positive serology for hepatitis C.
Show all 10Show fewer
- Evidence for active hepatitis B including positive serologies for HBsAg, HBeAg, or HBV-DNA. Note: If anti-HBs is positive, patient is eligible for study if liver enzymes are within the parameters indicated in the inclusion criteria
- Women who are breast-feeding
- Known allergy/sensitivity to study drug(s) or their formulations
- Patients with other OIs or intercurrent illness that could affect their ability to take study drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitario Prof. Edgard Santos/Universidade Federal da Bahia
Salvador, Estado de Bahia, 40110-160
About this study
Because drugs used to treat TB can reduce the amount of the anti-HIV drugs that reach the sites where the virus is located, this study is designed to see whether it is necessary to use higher doses of antiviral (anti-HIV) drugs while patients are receiving therapy with rifampin, one of the drugs commonly used to treat TB. Participants will be assigned to one of 4 arms (see below) and will be followed during the time when they are receiving both treatments.
Read the detailed description
This is an open label, randomized study with 4 arms: 1.) Standard dose and 2.) high dose nevirapine; and 3.) standard dose and 4.) high dose efavirenz. Subjects in all 4 arms will also receive 2 nucleoside analog drugs. Patients will have routine monitoring for the treatment of TB and HIV, as well as some additional blood samples to follow the virus in the blood and to determine the effect of the TB therapy on the amounts of anti-HIV drugs that are in the body.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- efavirenz or nevirapine
- Keywords
- Co-infection, Tuberculosis, HIV, Drug interactions, Non nucleoside reverse transcriptase inhibitors, Therapy, Treatment Naive
- Medical subject headings
- HIV Infections, Tuberculosis, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efavirenz or nevirapineDrug
Also called Sustiva (efavirenz), Viramune (nevirapine)
Patients co-infected with HIV and TB will receive either "standard" doses of nevirapine (200 mg 2x daily) or efavirenz (600 mg daily) or "high" doses of nevirapine (400 mg and 200 mg daily) or efavirenz (800 mg daily) that are chosen to compensate for the change in pharmacokinetics shown to occur when co-infected patients are treated with the antituberculous drug, rifampin.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard dose nevirapine (200 mg 2x daily) in combination with 2 nucleoside analogs Receives: Drug: efavirenz or nevirapine |
| 2 | Experimental | High dose nevirapine (400 mg in the morning, 200 mg in the evening) in combination with 2 nucleoside analogs Receives: Drug: efavirenz or nevirapine |
| 3 | Active comparator | Standard dose efavirenz (600 mg at bedtime) in combination with 2 nucleoside analogs Receives: Drug: efavirenz or nevirapine |
| 4 | Experimental | High dose efavirenz (800 mg at bedtime) in combination with 2 nucleoside analogs Receives: Drug: efavirenz or nevirapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline in HIV RNA in plasma Rise in CD4 cell count
These laboratory measures would be used to determine if there was a difference in the ARV failure rate between patients receiving standard dose vs high dose treatment with NNRTIs
Measured: Baseline, and Weeks 8, 20 and 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: A delay in protocol approval and approval of laboratory sites in Salvador, Brazil left too little time for completion of enrollment into the study.
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.
- More trials run by Stanford UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Investigators
- Terrence F Blaschke, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523458
- Sponsor's protocol ID
- Stanford Protocol ID: 95564
- Acronym
- OPTI-NNRTI
- Status last verified
- Jul 2011
- First submitted
- 29 Aug 2007
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Best Dose of Antivirals in Patients With Both TB and HIV
- ClinicalTrials.gov ID
- NCT00523458
- Acronym / sponsor ID
- OPTI-NNRTI / Stanford Protocol ID: 95564
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- Co-infection, Tuberculosis, HIV, Drug interactions, Non nucleoside reverse transcriptase inhibitors, Therapy, Treatment Naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A delay in protocol approval and approval of laboratory sites in Salvador, Brazil left too little time for completion of enrollment into the study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 31 Aug 2007 (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.
Because drugs used to treat TB can reduce the amount of the anti-HIV drugs that reach the sites where the virus is located, this study is designed to see whether it is necessary to use higher doses of antiviral (anti-HIV) drugs while patients are receiving therapy with rifampin, one of the drugs commonly used to treat TB. Participants will be assigned to one of 4 arms (see below) and will be followed during the time when they are receiving both treatments.
Detailed description
This is an open label, randomized study with 4 arms: 1.) Standard dose and 2.) high dose nevirapine; and 3.) standard dose and 4.) high dose efavirenz. Subjects in all 4 arms will also receive 2 nucleoside analog drugs. Patients will have routine monitoring for the treatment of TB and HIV, as well as some additional blood samples to follow the virus in the blood and to determine the effect of the TB therapy on the amounts of anti-HIV drugs that are in the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: efavirenz or nevirapineStandard dose nevirapine (200 mg 2x daily) in combination with 2 nucleoside analogs |
| 2 | Experimental | Drug: efavirenz or nevirapineHigh dose nevirapine (400 mg in the morning, 200 mg in the evening) in combination with 2 nucleoside analogs |
| 3 | Active comparator | Drug: efavirenz or nevirapineStandard dose efavirenz (600 mg at bedtime) in combination with 2 nucleoside analogs |
| 4 | Experimental | Drug: efavirenz or nevirapineHigh dose efavirenz (800 mg at bedtime) in combination with 2 nucleoside analogs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ARV naïve subjects
- Documented HIV infection
- Documented TB infection
- Platelet count 40,000/mm3
- Hemoglobin ≥8.0 g/dL
Key exclusion criteria (10 listed)
- Unable to provide informed consent.
- History drug abuse that the investigators suspect will interfere with compliance to study medications and visits.
- Patients on hemodialysis.
- Tuberculosis meningitis.
- Women with CD4 > 250 and men with CD4 > 400 due to higher risk of hepatotoxicity related to use of NVP.
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 |
|---|---|---|
| efavirenz or nevirapineAlso: Sustiva (efavirenz), Viramune (nevirapine)Patients co-infected with HIV and TB will receive either "standard" doses of nevirapine (200 mg 2x daily) or efavirenz (600 mg daily) or "high" doses of nevirapine (400 mg and 200 mg daily) or efavirenz (800 mg daily) that are chosen to compensate for the change in pharmacokinetics shown to occur when co-infected patients are treated with the antituberculous drug, rifampin. | Drug | 1, 2, 3, 4 |
Primary outcome
Decline in HIV RNA in plasma Rise in CD4 cell count
Time frame: Baseline, and Weeks 8, 20 and 32
These laboratory measures would be used to determine if there was a difference in the ARV failure rate between patients receiving standard dose vs high dose treatment with NNRTIs
Results and safety
The study was stopped early (reason given: A delay in protocol approval and approval of laboratory sites in Salvador, Brazil left too little time for completion of enrollment into the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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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.
Terrence F Blaschke, M.D. principal investigator
Stanford University
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 efavirenz or nevirapine in people with HIV Infections and Tuberculosis, run by Stanford University at 1 site in Brazil.
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 10 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: stopped early, as of the sponsor's last update on 22 Jul 2011. 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 Brazil. 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 was stopped early (reason given: A delay in protocol approval and approval of laboratory sites in Salvador, Brazil left too little time for completion of enrollment into the study.). Results are not available in the source record.
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?
Decline in HIV RNA in plasma Rise in CD4 cell count (time frame: Baseline, and Weeks 8, 20 and 32). 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 22 Jul 2011.