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NCT00002218 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002218
Other study ID # 278B
Secondary ID
Status Completed
Phase Phase 1
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date July 1998
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CI-1012

Locations
Country Name City State
United States Univ of Michigan Ann Arbor Michigan
United States Natl Institutes of Health Bethesda Maryland
United States Central Florida Research Initiative Maitland Florida
United States ViRx Inc Palm Springs California
United States Univ of Utah Med School / Clinical Trials Ctr Salt Lake City Utah
United States ViRx Inc San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Parke-Davis

Country where clinical trial is conducted

United States, 

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