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

NCT ID: NCT00002218

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CI-1012

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parke-Davis

INDUSTRY

Sponsor Role lead

Locations

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ViRx Inc

Palm Springs, California, United States

Site Status

ViRx Inc

San Francisco, California, United States

Site Status

Central Florida Research Initiative

Maitland, Florida, United States

Site Status

Natl Institutes of Health

Bethesda, Maryland, United States

Site Status

Univ of Michigan

Ann Arbor, Michigan, United States

Site Status

Univ of Utah Med School / Clinical Trials Ctr

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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278B

Identifier Type: -

Identifier Source: org_study_id