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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Parke-Davis
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002218

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 I

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

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

Estimated Enrollment:

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

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

Locations

United States, California
ViRx Inc
San Francisco, California, United States, 94109
ViRx Inc
Palm Springs, California, United States, 92262
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

Study ID Numbers:	278B
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002218 History of Changes
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:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 05, 2009