A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients
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To determine the maximum tolerated dose of CI-1012 in late-stage HIV-1-infected patients. To determine the antiretroviral activity of CI-1012 when added to combination therapy. To assess the multiple-dose pharmacokinetic characteristics of CT-1012 when added to combination therapy. To assess the effect of CI-1012 on the pharmacokinetics of other antiretroviral agents.
Condition or disease
Doses are escalated based on safety assessments: As soon as a dose meets the criteria for "tolerated" or "not tolerated", doses are escalated or terminated, respectively. All patients are treated for 2 weeks, with follow-up visits scheduled 1 week and 1 month post-treatment.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have:
Serological evidence of late-stage HIV-1 infection (ELISA and Western Blot).
CD4 T cell count less than or equal to 200 mm3.
HIV-1 RNA greater than or equal to 5,000 copies/mL.
Anti-HIV treatment within 8 weeks prior to entry.
Systemic steroids within 4 weeks prior to entry.
Treatment with anticancer agents within 4 weeks prior to study.