Safety and Tolerability of Z-100 in Patients With Early HIV Infection

This study has been terminated.

Sponsor:

Information provided by:

Zeria Pharmaceutical

ClinicalTrials.gov Identifier:

NCT00016692

First received: May 24, 2001

Last updated: April 26, 2006

Last verified: April 2001

History of Changes

Tracking Information

First Received Date ^ICMJE

May 24, 2001

Last Updated Date

April 26, 2006

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00016692 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Tolerability of Z-100 in Patients With Early HIV Infection

Official Title ^ICMJE

A Phase 1b Multicenter Double-Blind, Placebo-Controlled, Randomized Study on the Safety and Tolerability of Z-100 in Early HIV-1 Infected Patients

Brief Summary

The purpose of the study is to see if Z-100 (an investigational drug) treatment is safe in HIV patients who have never received treatment for their HIV, who have not been taking highly active antiretroviral therapy (HAART) for at least 8 weeks, or who have been stable on their current first or second HAART regimen for at least 12 weeks.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Masking: Double
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Z-100

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria

Patients may be eligible for this study if they:

Are HIV positive but do not show symptoms.
Are male or female, 18 years or older.
Have not received treatment for HIV.
Have received treatment but have discontinued HAART for at least 8 weeks prior to screening, have had stable viral loads on at least 2 separate time points at least 1 month apart including screening, and have had stable CD4 levels on at least 2 separate time points at least 1 month apart including screening.
Use birth control while on the study and during the follow-up period.
Have viral loads of 2,000 to 55,000 copies/ml within 2 weeks of randomization.
Have CD4 counts of greater than 350 cells/mm within 2 weeks of randomization.
Have a negative serum pregnancy test within 2 weeks of randomization (women able to have children).

Exclusion Criteria

Patients will not be eligible for this study if they:

Have failed HAART treatment.
Have opportunistic infection or cancer.
Have a history of tuberculosis.
Have very abnormal laboratory test results.
Have heart, liver, kidney or nervous system conditions.
Have serious problems digesting and absorbing food or have serious long-term diarrhea within 4
weeks of randomization.
Have received radiation (localized is allowed) or chemotherapy within 30 days before randomization.
Have seizure disorders that cannot be controlled.
Have received any other drugs that affect the immune system or experimental drugs within 60 days before randomization.
Have had any vaccination within 15 days before randomization.
Have a mental condition which makes the patient unable to understand what the study is about and what it involves.
Have a history of alcohol or drug abuse, unless the investigator feels that it will not interfere with participation in the protocol.
Are pregnant or breast-feeding.
Have a history of being very sensitive to the study drug or similar drugs.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00016692

Other Study ID Numbers ^ICMJE

B014
Zeria Protocol 85D10104

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Zeria Pharmaceutical

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Zeria Pharmaceutical

Verification Date

April 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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