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A Study of CI-1012 in HIV-Infected Patients

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ClinicalTrials.gov Identifier: NCT00002196
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: CI-1012 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00002196     History of Changes
Other Study ID Numbers: 278A
1012-005
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: July 1998

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases