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Safety and Tolerability of Z-100 in Patients with Early HIV Infection Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Safety and Tolerability of Z-100 in Patients with Early HIV Infection conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety and Tolerability of Z-100 in Patients with Early HIV Infection Clinical research trials and Safety and Tolerability of Z-100 in Patients with Early HIV Infection healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Safety and Tolerability of Z-100 in Patients with Early HIV Infection. Safety and Tolerability of Z-100 in Patients with Early HIV Infection Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and Tolerability of Z-100 in Patients with Early HIV Infection clinical trial. Human subjects often obtain the finest healthcare possible for their Safety and Tolerability of Z-100 in Patients with Early HIV Infection condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Tolerability of Z-100 in Patients with Early HIV Infection  Safety and Tolerability of Z-100 in Patients with Early HIV Infection
Safety and Tolerability of Z-100 in Patients with Early HIV Infection
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): Quintiles ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
UCSF - San Francisco Gen Hosp *Recruiting*
San Francisco, California, 94110
United States
Recruiting Anna Smith 415-476-9296
Univ TX Med Branch *Recruiting*
Galveston, Texas, 77555
United States
Recruiting Suzanne Lanier 409-747-0218
Northwestern Univ Med School *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Jim Bruce 312-695-4994
Additional Information:
Study ID Numbers: B014; Zeria Protocol 85D10104
Study Start Date:
Record last reviewed: April 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016692
Other Hiv Infections Studies:
1. A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible
2. The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients
3. A Phase I Study of the Safety and Immunogenicity of rgp120/HIV-1IIIB Vaccine in Healthy Adult Subjects (NOTE: Study extended ONLY for subjects who have previously received rgp120/HIV-1IIIB or rgp120/HIV-1MN on VEU 006 or VEU 006 Rollover study)
4. Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy
5. A Study to Evaluate the Use of Memantine In Combination with Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Safety and Tolerability of Z-100 in Patients with Early HIV Infection
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