A Study of CI-1012 in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002196
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: CI-1012
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
Official Title: A Phase I Multiple Oral, Rising-Dose, Tolerance and Pharmacokinetic Trial of CI-1012 in HIV-1-Infected Volunteers.

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 32
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002196

Locations
United States, California
ViRx Inc
Palm Springs, California, United States, 92262
ViRx Inc
San Francisco, California, United States, 94109
United States, Florida
Central Florida Research Initiative
Maitland, Florida, United States, 32751
United States, Maryland
Natl Institutes of Health
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Parke-Davis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002196     History of Changes
Other Study ID Numbers: 278A, 1012-005
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Dose-Response Relationship, Drug
Administration, Oral
Drug Administration Schedule
CD4 Lymphocyte Count
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 24, 2014