A Study of CI-1012 in HIV-Infected Patients

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CI-1012

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Dose-Response Relationship, Drug, Administration, Oral, Drug Administration Schedule, CD4 Lymphocyte Count, Anti-HIV Agents

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

ViRx Inc
ViRx Inc
Central Florida Research Initiative
Natl Institutes of Health

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002196

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Parke-Davis

1. Study Identification

Unique Protocol Identification Number

NCT00002196

Brief Title

A Study of CI-1012 in HIV-Infected Patients

Official Title

A Phase I Multiple Oral, Rising-Dose, Tolerance and Pharmacokinetic Trial of CI-1012 in HIV-1-Infected Volunteers.

Study Type

Interventional

2. Study Status

Record Verification Date

July 1998

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Parke-Davis

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Dose-Response Relationship, Drug, Administration, Oral, Drug Administration Schedule, CD4 Lymphocyte Count, Anti-HIV Agents

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

32 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

CI-1012

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

ViRx Inc

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

Facility Name

ViRx Inc

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

Facility Name

Central Florida Research Initiative

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

Natl Institutes of Health

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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