A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients

Launched by PARKE-DAVIS · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 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.
• • Exclusion Criteria
• Prior Medication:
• Excluded:
• • Anti-HIV treatment within 8 weeks prior to entry.
• • Systemic steroids within 4 weeks prior to entry.
• Prior Treatment:
• Excluded:
• • Treatment with anticancer agents within 4 weeks prior to study.