Trials / Unknown
UnknownNCT03478033
Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis
The Efficacy and Safety Evaluation of Standardized Treatment Included Rifampicin or Rifabutin in HIV/AIDs Patients Combined With Pulmonary Tuberculosis. A Prospective Study.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- Sponsor
- Shanghai Public Health Clinical Center · Other Government
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To compared the efficacy and safety of rifampicin and rifabutin which included in the standard treatment of anti-tuberculosis in HIV/AIDs patients combined with pulmonary tuberculosis, a multi-center, prospective cohort will be established. Antiviral efficacy and drug drug interaction will be investigated in order to provide optimized treatment for HIV/AIDs with tuberculosis.
Detailed description
Two hundreds and thirty participants will be randomly assigned to receive an anti--tuberculosis treatment include rifampicin or rifabutin for two months of intensive therapy. Isoniazid and rifampicin (or rifabutin) will be continued to use for four months of consolidation therapy. A total of followed up period will be 12 months. The antiretroviral therapy（ART） include: Tenofovir disoproxil fumarate 300mg/d +Lamivudine 300mg/d+ Efavirenz 600mg/d; or Zidovudine 300mg bid +Lamivudine 300mg/d +Efavirenz 600mg/d. ART will be started after 2 weeks of anti-tuberculosis. The follow-up visits include 2th, 4th, 6th, 8th, 12th,16th, 20th, 24th, 32th, 36th, 40th, 44th and 48th week. sputum smear, sputum culture, chest X-ray, CD4 Lymphocyte counts,HIV viral load and adverse event will be tested and recorded.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rifampicin | Rifampicin capsules, 150mg |
| DRUG | Rifabutin | Rifabutin capsules, 150mg |
Timeline
- Start date
- 2018-04-15
- Primary completion
- 2020-06-01
- Completion
- 2020-12-31
- First posted
- 2018-03-27
- Last updated
- 2018-04-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03478033. Inclusion in this directory is not an endorsement.