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A delay in protocol approval and approval of laboratory sites in Salvador, Brazil left too little time for completion of enrollment into the study.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Standard dose nevirapine (200 mg 2x daily) in combination with 2 nucleoside analogs |
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| 2 | Experimental | High dose nevirapine (400 mg in the morning, 200 mg in the evening) in combination with 2 nucleoside analogs |
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| 3 | Active Comparator | Standard dose efavirenz (600 mg at bedtime) in combination with 2 nucleoside analogs |
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| 4 | Experimental | High dose efavirenz (800 mg at bedtime) in combination with 2 nucleoside analogs |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efavirenz or nevirapine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, and Weeks 8, 20 and 32 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terrence F Blaschke, M.D. | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Prof. Edgard Santos/Universidade Federal da Bahia | Salvador | Estado de Bahia | 40110-160 | Brazil |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014376 | Tuberculosis |
| D060085 | Coinfection |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C098320 | efavirenz |
| D019829 | Nevirapine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |