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

April 26, 2006 updated by: Zeria Pharmaceutical

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • UCSF - San Francisco Gen Hosp
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med School
    • Texas
      • Galveston, Texas, United States, 77555
        • Univ TX Med Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeria Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 24, 2001

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

April 27, 2006

Last Update Submitted That Met QC Criteria

April 26, 2006

Last Verified

April 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B014
  • Zeria Protocol 85D10104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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