A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002218
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002218 on ClinicalTrials.gov Archive Site
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A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients
A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients

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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: CI-1012
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002218
278B
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Parke-Davis
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NIH AIDS Clinical Trials Information Service
July 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP