A Study of CI-1012 in HIV-Infected Patients

NCT ID: NCT00002196

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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CI-1012

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parke-Davis

INDUSTRY

Sponsor Role lead

Locations

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ViRx Inc

Palm Springs, California, United States

Site Status

ViRx Inc

San Francisco, California, United States

Site Status

Central Florida Research Initiative

Maitland, Florida, United States

Site Status

Natl Institutes of Health

Bethesda, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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1012-005

Identifier Type: -

Identifier Source: secondary_id

278A

Identifier Type: -

Identifier Source: org_study_id