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

Parke-Davis40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

CI-1012DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

ViRx Inc

Palm Springs, California, United States

ViRx Inc

San Francisco, California, United States

Central Florida Research Initiative

Maitland, Florida, United States

Natl Institutes of Health

Bethesda, Maryland, United States

Data from ClinicalTrials.gov

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