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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002218

Run by

Parke-Davis

People needed

40

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Univ of Michigan — Ann Arbor, Michigan, United States
• Univ of Utah Med School / Clinical Trials Ctr — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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