HIV-1NCT00337181
Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine Trial
An observational study of HIV-1, run by U.S. Army Medical Research and Development Command at 1 site in Thailand.
Trial summary
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 in reference to study NCT00223080 RV144. Read more about this study
- Who is it for?
- Ages 18 to 31 years
- Conditions the study is for
- HIV-1
- Type of treatment
- Vaccines
- How many people
- 114 participants
- Where
- 1 siteThailand
- Study dates
- May 2006to Jun 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 31 years
- All sexes
- No healthy volunteers
- Adult
Study population: All individuals who became HIV-infected after receiving experimental vaccine or placebo in the RV144 clinical trial if they received at least one injection
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Chon Buri Regional Hospital
Chon Buri, Chon Buri Province, 20000
About this study
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.
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 in reference to study NCT00223080 RV144. 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.
Read the detailed description
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.
- Conditions
- HIV-1
- Keywords
- HIV-1, Natural History, HIV vaccine, Thailand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Group | Received vaccination in RV144 | |
| Placebo Group | Received placebo in RV144 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reaching Clinical Long Term Component Endpoints
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
Measured: 66 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2006 (estimated)
- Study startMay 2006
- Primary completion1 Mar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- 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, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Supachai Rerks-Ngarm, MD, Principal investigator, Ministry of Health, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337181
- Sponsor's protocol ID
- A-11048
- Other IDs
- RV152
- Status last verified
- Aug 2018
- First submitted
- 14 Jun 2006
- Last updated
- 22 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rerks-Ngarm S, Paris RM, Chunsutthiwat S, Premsri N, Namwat C, Bowonwatanuwong C, Li SS, Kaewkungkal J, Trichavaroj R, Churikanont N, de Souza MS, Andrews C, Francis D, Adams E, Flores J, Gurunathan S, Tartaglia J, O'Connell RJ, Eamsila C, Nitayaphan S, Ngauy V, Thongcharoen P, Kunasol P, Michael NL, Robb ML, Gilbert PB, Kim JH. Extended evaluation of the virologic, immunologic, and clinical course of volunteers who acquired HIV-1 infection in a phase III vaccine trial of ALVAC-HIV and AIDSVAX B/E. J Infect Dis. 2013 Apr 15;207(8):1195-205. doi: 10.1093/infdis/jis478. Epub 2012 Jul 26.
PubMed 22837492
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00337181
- Acronym / sponsor ID
- A-11048
- Conditions
- HIV-1
- Keywords
- HIV-1, Natural History, HIV vaccine, Thailand
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- 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, a Sanofi Company
- Study start
- May 2006 (actual)
- Primary completion
- 1 Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Jun 2006 (estimated)
- Results
- Posted 22 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 in reference to study NCT00223080 RV144. 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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine Group | – | –Received vaccination in RV144 |
| Placebo Group | – | –Received placebo in RV144 |
Who may qualify
- Ages
- 18 to 31 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All individuals who became HIV-infected after receiving experimental vaccine or placebo in the RV144 clinical trial if they received at least one injection
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22837492Rerks-Ngarm S, Paris RM, Chunsutthiwat S, Premsri N, Namwat C, Bowonwatanuwong C, Li SS, Kaewkungkal J, Trichavaroj R, Churikanont N, de Souza MS, Andrews C, Francis D, Adams E, Flores J, Gurunathan S, Tartaglia J, O'Connell RJ, Eamsila C, Nitayaphan S, Ngauy V, Thongcharoen P, Kunasol P, Michael NL, Robb ML, Gilbert PB, Kim JH. Extended evaluation of the virologic, immunologic, and clinical course of volunteers who acquired HIV-1 infection in a phase III vaccine trial of ALVAC-HIV and AIDSVAX B/E. J Infect Dis. 2013 Apr 15;207(8):1195-205. doi: 10.1093/infdis/jis478. Epub 2012 Jul 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Supachai Rerks-Ngarm, MD principal investigator
Ministry of Health, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1, run by U.S. Army Medical Research and Development Command at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reaching Clinical Long Term Component Endpoints (time frame: 66 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00337181, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.