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Home > "E" Clinical Trials Conditions > Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand  Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
For Condition: HIV Infections,HIV Seronegativity
Status: Completed
Sponsor(s): VaxGen ,
Synopsis: The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect intravenous drug users from becoming infected with HIV.
Details: Volunteers are immunized and followed for a minimum of 2 years. Any volunteer that becomes infected with HIV-1 is followed every 4 months post infection for up to 36 months. Behavior effects associated with study participation are assessed.
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 20 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Volunteers may be eligible for this study if they: - Are 20 to 60 years old. - Are HIV-negative. - Have used intravenous drugs in the previous 12 months. - Are available and commit to 3 years of follow-up. - Have a Thai National ID or its equivalent such as government official ID or state enterprise ID. - Are able to understand the study and pass a test showing they understand it, and give written informed consent. Exclusion Criteria Volunteers will not be eligible for this study if they: - Have a serious disease or condition, or history of a serious disease or condition such as lymphoma, that would interfere with the study. - Are HIV-positive. - Have ever received an experimental HIV-1 vaccine. - Have had or expect to have any treatments or medications that interfere with the immune system (e.g., long-term use of systemic steroids, chemotherapy, or radiation). - Have received a vaccine or immunoglobulin within 2 weeks of receiving the first study injection, or other vaccines within 4 weeks of the first study injection. - Have received immunoglobulins for a long time. - Have received non-licensed, research agents within 4 weeks of the first study injection. - Expect to miss study visits or plan to move within 36 months. - Are pregnant or breast-feeding or plan to become pregnant during the 36-month study period. - Are women who have sex with men and do not plan to use effective birth control.
Total Enrollment: 2500
Location and Contact Information:
Overall Study Official:
KachitChoopanya, Principal Investigator,
Kachit Choopanya
Klongsan / Bangkok, ,
Thailand
Additional Information:
Study ID Numbers: VAX 003;
Study Start Date: March 1999
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006327
Other Hiv Infections Studies:
1. A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX
2. Comparing Single Photon Emission Computed Tomography (SPECT) and Liver Biopsy to Evaluate the Liver in Patients with HIV and Hepatitis C Virus
3. Prospective Study of HIV Infection in Hemophiliacs
4. Kidney Transplants in People with HIV Infection
5. A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children
Related Studies:
Other HIV Infections Clinical Trials
Other Clinical Trials
Other Klongsan / Bangkok Clinical Trials
Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
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