Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine Trial
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| ClinicalTrials.gov Identifier: NCT00337181 |
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Recruitment Status :
Completed
First Posted : June 15, 2006
Results First Posted : August 22, 2018
Last Update Posted : August 22, 2018
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| Condition or disease |
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| HIV-1 |
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 in reference to study NCT00223080 RV144. 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.
After enrollment in RV152, follow-up visits were scheduled at 0, 1, 3, and 6 months, and every 3 months thereafter. After month 12, CD4+ T cell counts and viral load were obtained at 6-month intervals until the CD4+ T cell count declined to <350/ul or highly-active antiretroviral therapy (HAART) was initiated, at which time CD4+ T cell counts and viral load were obtained every 3 months. Peripartum antiretroviral drugs given for prevention of mother-to-child-transmission was not considered a study endpoint, however HAART initiated during pregnancy and continued post-partum was counted. After a single CD4+ T-cell count < 350/ul a second sample was requested about 2 weeks later, and if the confirmatory measurement was >350/ul, a study endpoint was not registered and the volunteer resumed a normal visit schedule. A single genital fluid collection for viral load was obtained at the first RV152 visit. Clinical and laboratory data from RV144, including CD4+ T-cell and HIV-1 plasma viral load measurements, were linked to RV152 to inform primary and secondary protocol analyses as well as volunteer care and treatment.
| Study Type : | Observational |
| Actual Enrollment : | 114 participants |
| Observational Model: | Cohort |
| 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. |
| Actual Study Start Date : | May 2006 |
| Actual Primary Completion Date : | March 1, 2011 |
| Actual Study Completion Date : | June 2011 |
| Group/Cohort |
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Vaccine Group
Received vaccination in RV144
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Placebo Group
Received placebo in RV144
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- Number of Participants Reaching Clinical Long Term Component Endpoints [ Time Frame: 66 months ]Evaluate the vaccine effect on clinical long term endpoints: CD4 is for CD4<350 endpoint; ART is for initiation of highly-active antiretroviral therapy (HAART) endpoint; ADI is for AIDS-defining illness endpoint; A combination of multiple endpoints is listed in order of occurrences of the endpoints
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| Ages Eligible for Study: | 18 Years to 31 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- All individuals who become HIV-infected after receiving experimental vaccine or placebo in the RV144 clinical trial if they received at least one injection.
- The volunteer must give written, informed consent.
Exclusion Criteria:
- Persons who have a medical or psychiatric disorder, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
- Persons who become HIV-infected after the completion of the RV144 protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337181
| Thailand | |
| Chon Buri Regional Hospital | |
| Chon Buri, Chon Buri Province, Thailand, 20000 | |
| Principal Investigator: | Supachai Rerks-Ngarm, MD | Ministry of Health, Thailand |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | U.S. Army Medical Research and Materiel Command |
| ClinicalTrials.gov Identifier: | NCT00337181 History of Changes |
| Other Study ID Numbers: |
A-11048 RV152 ( Other Identifier: WRAIR ) |
| First Posted: | June 15, 2006 Key Record Dates |
| Results First Posted: | August 22, 2018 |
| Last Update Posted: | August 22, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by U.S. Army Medical Research and Materiel Command:
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HIV-1 Natural History HIV vaccine Thailand |
Additional relevant MeSH terms:
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Vaccines Immunologic Factors Physiological Effects of Drugs |