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

Tracking Information
First Submitted Date ICMJE	May 24, 2001
First Posted Date ICMJE	August 31, 2001
Last Update Posted Date	April 27, 2006
Study 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
Original Enrollment ICMJE	Not Provided
Study 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	No
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