HIVPhase 4NCT00329251
Study of the Influence of Vaccination in HIV Viral Load and Immunologic Responses Against HIV
A Phase 4 study testing Hepatitis A, Hepatitis B and Influenza in people with HIV, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether an immunization schedule is beneficial to HIV-infected patients with CD4 recount over 500 cells/mm3 and undetectable viral load. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Hepatitis A, Hepatitis B and Influenza
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2003to Mar 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Asymptomatic HIV infection
- CD4>500/mm3 >6 months prior to inclusion
- CD4 nadir >300/mm3
- Being under HAART > 1 year prior to inclusion
- Viral load<200 copies/mL > 6 months prior to inclusion
- Viral load previous to treatment >5000 copies/mL
- Informed consent
Who cannot join
- Pregnant women
- Basal creatinine >2.5 mg/dL
- Allergy to either a vaccine or a ingredient of it
- Chronic hepatitis B
- GOT/GPT > 250 IU/L
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Infectious Diseases, Hospital Clínic, C/Villarroel 170
Barcelona, Barcelona, 08036
About this study
Official title: Study of the Influence of Immunological Repeated Stimuli With Commercial Vaccines Over the Viral Load (VL), Resistance Development and Specific Immunological Response Against HIV in Early Stage HIV Patients With Undetectable VL After HAART
The purpose of this study is to determine whether an immunization schedule is beneficial to HIV-infected patients with CD4 recount over 500 cells/mm3 and undetectable viral load.
Read the detailed description
As HIV-infected patients are considered immunocompromised, it is generally recommended that they have to receipt appropriate vaccines. However data are conflicting concerning potential harmful effects following the administration of commercial vaccines in HIV-infected patients. Transient increases ("blips") in the viral load have been described associated with a single dose of vaccine, with the potential risk of developing resistance to HAART. On the other hand, there has been described that patients with blips can have an increase in HIV-specific immune responses, which may help to improve the viral control.
Comparison: We have performed a clinical trial to evaluate the effect of a vaccination program in successfully treated HIV-infected adults on HAART compared to placebo.
- Conditions
- HIV
- Being tested
- Hepatitis A, Hepatitis B, Influenza, Pneumococcal, Tetanus-diphteria
- Keywords
- HIV, Viral load, Vaccines, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis ABiological
Hepatitis BBiological
InfluenzaBiological
PneumococcalBiological
Tetanus-diphteriaBiological
VaricellaBiological
Measles-Mumps-RubellaBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Times viral load increases over 20.000 copies/mL.
Secondary outcomes (7)
Development of resistance to antiretroviral therapy during the 18 months of the study
Appearance of specific CD4 proliferative responses against HIV during the 18 months of the study
Appearance of specific cytotoxic responses against HIV during the 18 months of the study
Number of patients under 5000 copies/mL after 6 months of stopping HAART
Development of symptoms C during the 18 months of the study
Deaths during the 18 months of the study
Toxicity during the 18 months of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startApr 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 26 participants
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- José Mª Gatell, MD, Study chair, Hospital Clínic of BarcelonaJosé Mª Miró, MD, Study chair, Hospital Clínic of BarcelonaJosé Mª Bayas, MD, Study chair, Hospital Clínic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329251
- Sponsor's protocol ID
- 02-0490; EARTH-06
- Other IDs
- VAC-01
- Status last verified
- May 2006
- First submitted
- 22 May 2006
- Last updated
- 24 May 2006
- Results posted
- No
Publications
Yek C, Gianella S, Plana M, Castro P, Scheffler K, Garcia F, Massanella M, Smith DM. Standard vaccines increase HIV-1 transcription during antiretroviral therapy. AIDS. 2016 Sep 24;30(15):2289-98. doi: 10.1097/QAD.0000000000001201.
PubMed 27427877Castro P, Torres B, Lopez A, Gonzalez R, Vilella A, Nicolas JM, Gallart T, Pumarola T, Sanchez M, Leal M, Vallejo A, Bayas JM, Gatell JM, Plana M, Garcia F. Effects of different antigenic stimuli on thymic function and interleukin-7/CD127 system in patients with chronic HIV infection. J Acquir Immune Defic Syndr. 2014 Aug 15;66(5):466-72. doi: 10.1097/QAI.0000000000000207.
PubMed 24820104Castro P, Plana M, Gonzalez R, Lopez A, Vilella A, Nicolas JM, Gallart T, Pumarola T, Bayas JM, Gatell JM, Garcia F. Influence of episodes of intermittent viremia ("blips") on immune responses and viral load rebound in successfully treated HIV-infected patients. AIDS Res Hum Retroviruses. 2013 Jan;29(1):68-76. doi: 10.1089/AID.2012.0145. Epub 2012 Dec 16.
PubMed 23121249
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Influence of Immunological Repeated Stimuli With Commercial Vaccines Over the Viral Load (VL), Resistance Development and Specific Immunological Response Against HIV in Early Stage HIV Patients With Undetectable VL After HAART
- ClinicalTrials.gov ID
- NCT00329251
- Acronym / sponsor ID
- 02-0490; EARTH-06
- Conditions
- HIV
- Keywords
- HIV, Viral load, Vaccines, Immunotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Mar 2006
- First posted
- 24 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether an immunization schedule is beneficial to HIV-infected patients with CD4 recount over 500 cells/mm3 and undetectable viral load.
Detailed description
As HIV-infected patients are considered immunocompromised, it is generally recommended that they have to receipt appropriate vaccines. However data are conflicting concerning potential harmful effects following the administration of commercial vaccines in HIV-infected patients. Transient increases ("blips") in the viral load have been described associated with a single dose of vaccine, with the potential risk of developing resistance to HAART. On the other hand, there has been described that patients with blips can have an increase in HIV-specific immune responses, which may help to improve the viral control.
Comparison: We have performed a clinical trial to evaluate the effect of a vaccination program in successfully treated HIV-infected adults on HAART compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >18 years
- Asymptomatic HIV infection
- CD4>500/mm3 >6 months prior to inclusion
- CD4 nadir >300/mm3
- Being under HAART > 1 year prior to inclusion
Key exclusion criteria (5 listed)
- Pregnant women
- Basal creatinine >2.5 mg/dL
- Allergy to either a vaccine or a ingredient of it
- Chronic hepatitis B
- GOT/GPT > 250 IU/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis A | Biological | – |
| Hepatitis B | Biological | – |
| Influenza | Biological | – |
| Pneumococcal | Biological | – |
| Tetanus-diphteria | Biological | – |
| Varicella | Biological | – |
| Measles-Mumps-Rubella | Biological | – |
Primary outcome
Times viral load increases over 20.000 copies/mL.
7 secondary outcomes
Development of resistance to antiretroviral therapy during the 18 months of the study
Appearance of specific CD4 proliferative responses against HIV during the 18 months of the study
Appearance of specific cytotoxic responses against HIV during the 18 months of the study
Number of patients under 5000 copies/mL after 6 months of stopping HAART
Development of symptoms C during the 18 months of the study
Deaths during the 18 months of the study
Toxicity during the 18 months of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2006.
- Derived from this study: PubMed 27427877Yek C, Gianella S, Plana M, Castro P, Scheffler K, Garcia F, Massanella M, Smith DM. Standard vaccines increase HIV-1 transcription during antiretroviral therapy. AIDS. 2016 Sep 24;30(15):2289-98. doi: 10.1097/QAD.0000000000001201.
- Derived from this study: PubMed 24820104Castro P, Torres B, Lopez A, Gonzalez R, Vilella A, Nicolas JM, Gallart T, Pumarola T, Sanchez M, Leal M, Vallejo A, Bayas JM, Gatell JM, Plana M, Garcia F. Effects of different antigenic stimuli on thymic function and interleukin-7/CD127 system in patients with chronic HIV infection. J Acquir Immune Defic Syndr. 2014 Aug 15;66(5):466-72. doi: 10.1097/QAI.0000000000000207.
- Derived from this study: PubMed 23121249Castro P, Plana M, Gonzalez R, Lopez A, Vilella A, Nicolas JM, Gallart T, Pumarola T, Bayas JM, Gatell JM, Garcia F. Influence of episodes of intermittent viremia ("blips") on immune responses and viral load rebound in successfully treated HIV-infected patients. AIDS Res Hum Retroviruses. 2013 Jan;29(1):68-76. doi: 10.1089/AID.2012.0145. Epub 2012 Dec 16.
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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.
José Mª Gatell, MD study chair
Hospital Clínic of Barcelona
José Mª Miró, MD study chair
Hospital Clínic of Barcelona
José Mª Bayas, MD study chair
Hospital Clínic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hepatitis A, Hepatitis B and Influenza in people with HIV, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 8 inclusion and 5 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 24 May 2006. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Times viral load increases over 20.000 copies/mL.. 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 NCT00329251, which also lists 3 linked publications.
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 24 May 2006.