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

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

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.

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.

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.