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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Z-100
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 1b Multicenter Double-Blind, Placebo-Controlled, Randomized Study on the Safety and Tolerability of Z-100 in Early HIV-1 Infected Patients

Resource links provided by NLM:


Further study details as provided by Zeria Pharmaceutical:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016692

Locations
United States, California
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, Texas
Univ TX Med Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
Zeria Pharmaceutical
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00016692     History of Changes
Other Study ID Numbers: B014, Zeria Protocol 85D10104
Study First Received: May 24, 2001
Last Updated: April 26, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Zeria Pharmaceutical:
Drug tolerance
Acute Infection

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Specific substance maruyama
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014