A Study of CI-1012 in HIV-Infected Patients

P

Parke-Davis

Status and phase

Completed
Phase 1

Conditions

HIV Infections

Treatments

Drug: CI-1012

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002196
278A
1012-005

Details and patient eligibility

About

The purpose of this study is to see if it is safe and effective to give CI-1012 to HIV-infected patients who do not have any symptoms of the disease. This study also examines how the body handles CI-1012.

Full description

Patients receive 2 weeks of oral CI-1012 therapy in this open-label study, with 8 patients entered at each dose level studied.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients must have:

  • Serologic evidence of infection with HIV-1.
  • CD4+ cell count >= 200 cells/mm3.
  • HIV-1 RNA >= 10,000 copies/ml.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

Viral, fungal, or bacterial infection requiring therapy other than topical medications.

Concurrent Medication:

Excluded:

  • Prophylactic systematic antibacterial, antifungal or antiviral agents.
  • Antiretroviral therapy. NOTE:
  • Patient must be willing to remain off antiretroviral therapy for 1 week after completing study medication.

Prior Medication:

Excluded:

  • Experimental therapy for >= 4 weeks prior to initiation of study medication.
  • Antiretroviral treatment for 3 weeks prior to initiation of study medication.
  • Systemic steroids or anticancer agents for 4 weeks prior to initiation of study medication.

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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