A Phase 2 interventional study of HAART containing nevirapine in HIV Infections and Tuberculosis, sponsored by The HIV Netherlands Australia Thailand Research Collaboration. Completed at 6 sites in Thailand. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-07-17.
Sponsored by The HIV Netherlands Australia Thailand Research Collaboration · Phase 2, Interventional, and Treatment
A 48 week, randomized, open-label, two arm study to compare the efficacy, safety and tolerability of HAART containing nevirapine 400 mg/day versus nevirapine 600 mg/day in HIV-1 infected patients started at 2-6 weeks after initiating rifampicin containing antituberculosis therapy.
Preliminary data from the HIVNAT PK laboratory indicate that out of 5/60 patients treated with nevirapine (200 mg bid) and rifampicin had sub-therapeutic nevirapine levels (\<3.0 mg mg/L). In a control group of 38 patients using nevirapine without rifampicin there were no sub-therapeutic levels. A dose increase of nevirapine while patients who are receiving that rifampicin may be required. Both nevirapine and rifampicin are tepatotoxic agents as are other agents used in treatment of HIV or tuberculosis. Using a higher nevirapine may prevent the occurrence of sub-therapeutic nevirapine levels, but may also induce more liver toxicity. To address these issues, we designed a randomized prospective study to evaluate the safety, efficacy and pharmacokinetics of nevirapine 400 mg/day versus 600 mg/day with a two weeks lead-in 200 mg/day and 400 mg/day respectively, in TB-HIV co-infected patients who taking rifampicin and short-term efficacy and toxicity.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 42 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →The HIV Netherlands Australia Thailand Research Collaboration is the lead sponsor of 59 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
NVP 400 mg
Drug: HAART containing nevirapine
NVP 600 mg
Drug: HAART containing nevirapine
Initially NVP 200 mg BID (400 mg per day) was compared to 400 mg BID and 200 mg OD NVP (600 mg per day). 400 mg/day versus 600 mg/day.
Efficacy of nevirapine based HAART 400 mg/day versus 600 mg/day on HIV-1 load as measured by HIV-1 RNA quantification in plasma
Time frame: 48 weeks
Safety and tolerability of nevirapine based HAART 400 mg/day versus 600 mg/day
Time frame: 48 weeks
Nevirapine level at week 2, 4 and 12 and 12 hour PK at week 4 (only 20 patients)
Time frame: 48 weeks
Immune recovery syndrome, adherence, clinical improvement, incidence of new/recurrent AIDS events (CDC class C) between two group
Time frame: 48 weeks
Time to mortality or new/recurrent AIDS events (CDC class C), 1 year mortality rate of TB/HIV patients, emerging of ARV resistant especially nevirapine, emerging of anti-TB resistance
Time frame: 48 weeks
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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The HIV Netherlands Australia Thailand Research Collaboration