A Study to Determine the Best Dose of Antivirals in Patients With Both TB and HIV (OPTI-NNRTI)
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ClinicalTrials.gov Identifier: NCT00523458 |
Recruitment Status
:
Terminated
(A delay in protocol approval and approval of laboratory sites in Salvador, Brazil left too little time for completion of enrollment into the study.)
First Posted
: August 31, 2007
Last Update Posted
: July 22, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Tuberculosis | Drug: efavirenz or nevirapine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | March 2008 |
Actual Study Completion Date : | March 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Standard dose nevirapine (200 mg 2x daily) in combination with 2 nucleoside analogs
|
Drug: efavirenz or 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.
Other Names:
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Experimental: 2
High dose nevirapine (400 mg in the morning, 200 mg in the evening) in combination with 2 nucleoside analogs
|
Drug: efavirenz or 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.
Other Names:
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Active Comparator: 3
Standard dose efavirenz (600 mg at bedtime) in combination with 2 nucleoside analogs
|
Drug: efavirenz or 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.
Other Names:
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Experimental: 4
High dose efavirenz (800 mg at bedtime) in combination with 2 nucleoside analogs
|
Drug: efavirenz or 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.
Other Names:
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- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523458
Brazil | |
Hospital Universitario Prof. Edgard Santos/Universidade Federal da Bahia | |
Salvador, Bahia, Brazil, 40110-160 |
Principal Investigator: | Terrence F Blaschke, M.D. | Stanford University |
Responsible Party: | Terrence F Blaschke, Principle Investigator, Stanford University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00523458 History of Changes |
Other Study ID Numbers: |
Stanford Protocol ID: 95564 |
First Posted: | August 31, 2007 Key Record Dates |
Last Update Posted: | July 22, 2011 |
Last Verified: | July 2011 |
Keywords provided by Stanford University:
Co-infection Tuberculosis HIV Drug interactions |
Non nucleoside reverse transcriptase inhibitors Therapy Treatment Naive |
Additional relevant MeSH terms:
HIV Infections Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Efavirenz |
Nevirapine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Anti-HIV Agents |