A Study of CI-1012 in HIV-Infected Patients - Full Text View

Purpose

The purpose of this study is to see if it is safe and effective to give CI-1012 to HIV-infected patients who do not have any symptoms of the disease. This study also examines how the body handles CI-1012.

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

MedlinePlus related topics:

AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Pharmacokinetics Study

Official Title:	A Phase I Multiple Oral, Rising-Dose, Tolerance and Pharmacokinetic Trial of CI-1012 in HIV-1-Infected Volunteers.

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

Estimated Enrollment:

32

Detailed Description:

Patients receive 2 weeks of oral CI-1012 therapy in this open-label study, with 8 patients entered at each dose level studied.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

Serologic evidence of infection with HIV-1.
CD4+ cell count >= 200 cells/mm3.
HIV-1 RNA >= 10,000 copies/ml.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

Viral, fungal, or bacterial infection requiring therapy other than topical medications.

Concurrent Medication:

Excluded:

Prophylactic systematic antibacterial, antifungal or antiviral agents.
Antiretroviral therapy. NOTE:
Patient must be willing to remain off antiretroviral therapy for 1 week after completing study medication.

Prior Medication:

Excluded:

Experimental therapy for >= 4 weeks prior to initiation of study medication.
Antiretroviral treatment for 3 weeks prior to initiation of study medication.
Systemic steroids or anticancer agents for 4 weeks prior to initiation of study medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002196

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

Sponsors and Collaborators

Parke-Davis

More Information

Study ID Numbers:	278A, 1012-005
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002196
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Dose-Response Relationship, Drug

Administration, Oral

Drug Administration Schedule

CD4 Lymphocyte Count

Anti-HIV Agents

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	Parke-Davis
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002196