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| Sponsor: | U.S. Army Office of the Surgeon General |
|---|---|
| Collaborators: | U.S. Army Medical Research and Materiel Command Walter Reed Army Institute of Research (WRAIR) Royal Thai Ministry of Public Health Mahidol University Armed Forces Research Institute of Medical Sciences, Thailand Sanofi Pasteur MSD Global Solutions for Infectious Diseases |
| Information provided by: | Walter Reed Army Institute of Research (WRAIR) |
| ClinicalTrials.gov Identifier: | NCT00337181 |
Purpose
This protocol will study the clinical course of HIV-infection among volunteers who have received either a placebo injection or the experimental vaccine combination of ALVAC-HIV and AIDSVAX B/E prior to HIV-1 infection. The study will assess whether those who received the experimental vaccine combination have a slower progression of HIV disease compared to those who received the placebo injection.
| Condition |
|---|
| HIV-1 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Extended Evaluation of the Virologic, Immunologic, and Clinical Course of Volunteers Who Become HIV-1 Infected During Participation in a Phase III Vaccine Trial of ALVAC-HIV and AIDSVAX® B/E. |
| Estimated Enrollment: | 130 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | May 2013 |
Prospective cohort study of the clinical course of HIV-1 infection occurring after candidate HIV-1 vaccination (breakthrough infection) with ALVAC-HIV (vcP1521) and AIDSVAX B/E. This study will enroll volunteers who become HIV-infected during the course of follow up in a phase III preventive HIV vaccine trial conducted in Rayong and Chon Buri, Thailand. Volunteers will be enrolled in this protocol to provide additional long-term follow up to establish whether differences in viral load after infection (comparing vaccine to placebo) are associated with altered disease outcomes, as well as provide more detailed immunologic and virologic assessment of these volunteers.
Eligibility| Ages Eligible for Study: | 18 Years to 31 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Thailand | |
| Chon Buri Regional Hospital | |
| Muang District, Chon Buri Province, Thailand, 20000 | |
| Principal Investigator: | Supachai Rerks-Ngarm, MD | Ministry of Health, Thailand |
More Information
| ClinicalTrials.gov Identifier: | NCT00337181 History of Changes |
| Other Study ID Numbers: | WRAIR 1184, RV152, CBER BB IND-8795 |
| Study First Received: | June 14, 2006 |
| Last Updated: | June 2, 2010 |
| Health Authority: | United States: Office of the Surgeon General United States: US Medical Materiel Agency United States: Federal Government |
| HIV-1 Natural History HIV vaccine Thailand |
