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| Name | Class |
|---|---|
| Mahidol University | OTHER |
| Chulalongkorn University | OTHER |
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The randomized controlled trial is conducted among antiretroviral naive co-infected HIV and tuberculosis patients who receiving rifampicin-based antituberculous regimen fro at least 4 weeks butt not exceed 16 weeks before enrolment. All patients receive the same backbone regimen of stavudine (30 mg/40 mg twice daily)+ lamivudie 150 mg twice daily. They are randomized to receive nevirapine 400 mg/day twice daily vs efavirenz 600 mg/day at bed time. All patients are followed through 144 weeks after initiation of antiviral therapy. The primary objective are to compare the proportion of patient who achieve undetectable plasma HIV-1RNA<50 copies/ml at week 48. The previous reports demonstrated that the standard doses of both nevirapine and efavirenz coulde be used among co-infected HIV and tuberculosis patients who receiving rifampicin even though plasma levels are somewhat reduced by rifampicin. However, there have been not been a randomized control trial to compare these two regimens. Thus, this trial will provide the efficacy data between these two regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efavirenz | Experimental | Efavirenz 600 mg/day + stavudine +lamivudine |
|
| Nevirapine | Experimental | Nevirapine 400 mg/day + stavudine +lamivudine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efavirenz | Drug | efavirenz 600 mg/day + stavudine + lamivudine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To compare proportion of patients who achieved undetectable plasma HIV-1RNA< 50 copies/mL at 48 weeks after initiation of antiretroviral treatment between the 2 groups | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| to compare CD4 response at 48, 96 and 144 weeks after initiation of antiretroviral treatment, to compare adverse drugs reaction between the 2 groups | 144 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weerawat Manosuthi, MD | Bamrasnaradura Infectious Diseases Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bamrasnaradura Infectious Diseases Institute | Nonthaburi | Changwat Nonthaburi | 11000 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19438397 | Derived | Manosuthi W, Sungkanuparph S, Tantanathip P, Lueangniyomkul A, Mankatitham W, Prasithsirskul W, Burapatarawong S, Thongyen S, Likanonsakul S, Thawornwa U, Prommool V, Ruxrungtham K; N2R Study Team. A randomized trial comparing plasma drug concentrations and efficacies between 2 nonnucleoside reverse-transcriptase inhibitor-based regimens in HIV-infected patients receiving rifampicin: the N2R Study. Clin Infect Dis. 2009 Jun 15;48(12):1752-9. doi: 10.1086/599114. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014376 | Tuberculosis |
| 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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| nevirapine |
| Drug |
nevirapine 400 mg/day + stavudine +lamivudine |
|
| 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 |