Back to resultsA Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CI-1012
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Dose-Response Relationship, Drug, Anti-HIV Agents
Eligibility Criteria
Inclusion Criteria Patients must have: Serological evidence of late-stage HIV-1 infection (ELISA and Western Blot). CD4 T cell count less than or equal to 200 mm3. HIV-1 RNA greater than or equal to 5,000 copies/mL. Exclusion Criteria Prior Medication: Excluded: Anti-HIV treatment within 8 weeks prior to entry. Systemic steroids within 4 weeks prior to entry. Prior Treatment: Excluded: Treatment with anticancer agents within 4 weeks prior to study.
Sites / Locations
- ViRx Inc
- ViRx Inc
- Central Florida Research Initiative
- Natl Institutes of Health
- Univ of Michigan
- Univ of Utah Med School / Clinical Trials Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002218
Brief Title
A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients
Official Title
A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Parke-Davis
4. Oversight
5. Study Description
Brief Summary
To determine the maximum tolerated dose of CI-1012 in late-stage HIV-1-infected patients. To determine the antiretroviral activity of CI-1012 when added to combination therapy. To assess the multiple-dose pharmacokinetic characteristics of CT-1012 when added to combination therapy. To assess the effect of CI-1012 on the pharmacokinetics of other antiretroviral agents.
Detailed Description
Doses are escalated based on safety assessments: As soon as a dose meets the criteria for "tolerated" or "not tolerated", doses are escalated or terminated, respectively. All patients are treated for 2 weeks, with follow-up visits scheduled 1 week and 1 month post-treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Dose-Response Relationship, Drug, Anti-HIV Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
40 (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
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients must have:
Serological evidence of late-stage HIV-1 infection (ELISA and Western Blot).
CD4 T cell count less than or equal to 200 mm3.
HIV-1 RNA greater than or equal to 5,000 copies/mL.
Exclusion Criteria
Prior Medication:
Excluded:
Anti-HIV treatment within 8 weeks prior to entry.
Systemic steroids within 4 weeks prior to entry.
Prior Treatment:
Excluded:
Treatment with anticancer agents within 4 weeks prior to study.
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
Facility Name
Univ of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Univ of Utah Med School / Clinical Trials Ctr
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients
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