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Sponsored by: |
Zeria Pharmaceutical |
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Information provided by: | Zeria Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00016692 |
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 |
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HIV Infections |
Drug: Z-100 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
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 |
Study ID Numbers: | B014, Zeria Protocol 85D10104 |
Study First Received: | May 24, 2001 |
Last Updated: | April 26, 2006 |
ClinicalTrials.gov Identifier: | NCT00016692 |
Health Authority: | United States: Food and Drug Administration |
Drug tolerance Acute Infection |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Specific substance maruyama |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Adjuvants, Immunologic Lentivirus Infections Infection Pharmacologic Actions |