Stopped: Insufficient accrual rate
This study evaluates the safety, tolerability, pharmacokinetics, and efficacy of treating Cryptosporidiosis in HIV positive patients with Clofazimine. Half of the HIV positive patients with Cryptosporidiosis enrolled will be treated with Clofazimine while the other half will be given placebo. An additional group of HIV positive patients without Cryptosporidium infection or diarrhea will be given Clofazimine to assess the differences in pharmacokinetics between HIV positive patients with and without Cryptosporidiosis and diarrhea.
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Reduction in Cryptosporidium fecal shedding following Clofazimine administration
Timeframe: 5 days
Pharmacokinetics (area under curve) of Clofazimine in HIV-infected subjects with Cryptosporidium and diarrhea versus HIV-infected subjects without Cryptosporidium infection or diarrhea
Timeframe: 5 days
Peak plasma concentration of Clofazimine in HIV-infected subjects with Cryptosporidium and diarrhea versus HIV-infected subjects without Cryptosporidium infection or diarrhea
Timeframe: 5 days
Pharmacokinetics (Ke) of Clofazimine in HIV-infected subjects with Cryptosporidium and diarrhea versus HIV-infected subjects without Cryptosporidium infection or diarrhea
Timeframe: 5 days
Stool pharmacokinetics of Clofazimine in HIV-infected subjects with Cryptosporidium and diarrhea versus HIV-infected subjects without Cryptosporidium infection or diarrhea
Timeframe: 5 days
Frequency and severity of solicited adverse events (AEs)
Timeframe: 5 days
Frequency, severity, and relationship to study product of unsolicited AEs
Timeframe: 55 days
Occurrence of serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and adverse events of special interest (AESI).
Timeframe: 55 days