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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: CI-1012
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 40
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002218

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
United States, Michigan
Univ of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Utah
Univ of Utah Med School / Clinical Trials Ctr
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Parke-Davis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002218     History of Changes
Other Study ID Numbers: 278B
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Dose-Response Relationship, Drug
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 28, 2014