HIVPhase 1NCT00796770
Vaccination of HIV-1 Infected Patients With Dendritic Cells in Addition to Antiretroviral Treatment - (DALIA Trial)
A Phase 1 study testing Dendritic Cell Vaccine in people with HIV, run by Baylor Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the administration of a dendritic cell vaccine is a safe and effective treatment for HIV-1 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Dendritic Cell Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Sep 2011
- Phase
- Phase 1
- 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
- ≥ 18 years old
- written informed consent
- HIV1 infection documented by any licensed ELISA test kit and confirmed by Western Blot at anytime prior to study entry
- on treatment with a combination of antiviral drugs (HAART) for at least 12 months, and stable on treatment for at least 3 months prior to enrollment. HAART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral drugs (other than 3 Nucs only and low dose ritonavir used for boosting other protease inhibitors does not count as one of these three antiretroviral agents)
- CD4+ T cell counts > 500 cells/mm3 on at least two consecutive measurements (including the screening value) within the previous 6 months prior to enrollment (occasional CD4 cell counts ranging between 450-500 cells/mm3 is permitted)
- nadir CD4+ T cell counts > 300 cells/mm3 prior HAART
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- plasma HIV-RNA ≤ 50 copies/mL on at least two consecutive measurements (including the screening value) within the previous 3 months prior to enrollment (occasional so called 'blips' up to 200 copies/mL are permitted)
- no history of CDC class C event (Appendix 2)
- no vaccination in the last 3 months
- blood cells and chemistry:
- neutrophils ≥ 1,000/mm3
- platelets ≥ 100,000/mm3
- hemoglobin ≥ 10 g/dl
- creatinin ≤ 1.5 x N
- ASAT, ALAT, conjugated bilirubin ≤ 2.5 x N
- Adequate Kidney Function proteinuria ≤ 1 g/l (++)by urinalysis
Who cannot join
- Nadir CD4+ T cell counts < 300 cells/mm3 prior HAART
- pregnant or lactating woman
- any prior chemotherapy treatment
- interferon alpha (IFN-α-2b) or sargramostim (GM-CSF) < 12 weeks before the beginning of the trial
- interleukin-2 (IL-2) <12 weeks before the beginning of the trial,
- corticosteroids or other immunosuppressive agents <12 weeks before beginning the trial
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- active asthma and/or on treatment for asthma,
- any history of malignancy (except basal carcinoma of the skin) including any hematologic malignancy or AIDS defining malignancy, such as lymphoproliferative disorder or Kaposi's sarcoma. Patients with Kaposi's sarcoma limited to the skin that disappeared while on HAART therapy, and without requiring any other systemic therapy, 1 year prior to study entry will be eligible to participate
- angina pectoris or with congestive heart failure, with auto-immune disease, or evolutive pulmonary disease, or organ failure
- active infections including viral hepatitis
- history of thrombocytopenia
- chronic hepatitis B or C
- previous exposure to any HIV experimental vaccine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75204
About this study
Official title: Vaccination of HIV-1 Infected Patients With Ex-vivo Generated Interferon-α Dendritic Cells Loaded With HIV-1 Lipopeptides and Activated With Lipopolysaccharide in Addition to Antiretroviral Treatment: Exploratory Phase I Study-(DALIA Trial)
The purpose of this study is to determine whether the administration of a dendritic cell vaccine is a safe and effective treatment for HIV-1 patients.
Read the detailed description
The purpose of this study is to determine whether the administration of a dendritic cell vaccine is a safe and effective treatment for HIV-1 patients. This will be a phase I, single-center, study in HIV infected patients. The primary objective is to evaluate safety of the vaccination schedule (from apheresis procedure to week 24) at week 24 and safety of the Analytical Treatment Interruption (ATI; from week 24 to week 48) at week 48 in HIV-1 infected patients who have been receiving antiretroviral therapy for at least 12 months with HIV-1 RNA ≤50 copies/mL and CD4+ T cell counts >500/mm3 at entry in the trial and who received, in addition to anti-retroviral therapy for 24 weeks, vaccination with ex vivo generated interferon-alpha dendritic cells loaded with HIV-1 lipopeptides and activated with lipopolysaccharide (BIIR/ANRS-HIVax-001, the DC vaccine product).
- Conditions
- HIV
- Being tested
- Dendritic Cell Vaccine
- Keywords
- HIV, Vaccine, HAART, HIV-1, AIDS, Dendritic Cells, DALIA
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic Cell VaccineBiological
Biological/Vaccine: Experimental: Dendritic Cell Vaccine Patients will receive 4 doses of the vaccine at weeks 0, 4, 8 and 12. The vaccine will be injected subcutaneously, in 3 separate injection sites in the upper and lower extremities.
At week 24, patients will have HAART treatment interrupted. The HAART treatment will be resumed at week 48 or earlier at any time point if one of the following occur:
- two consecutive measurements of CD4+ T cell count below 350x10e6 cells/L and/or 25% of total lymphocytes within at least a 2 weeks
- an opportunistic infection
- a CDC class C-defining event (defined in appendix 2)
- a serious non-AIDS defining event.
Patients will have follow-up visits on weeks: 22, 24, 25, 26, 27, 28, 32, 36, 40, 44, and 48.
| Study group | Role | What they receive |
|---|---|---|
| Dendritic Cell Vaccine | Experimental | Autologous dendritic cells generated using GM-CSF and interferon alpha, loaded with HIV lipopeptides and activated with lipopolysaccharide Receives: Biological: Dendritic Cell Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of the vaccination schedule at week 24 and the safety of the Analytical Treatment Interruption at week 48 in HIV-1 infected patients.
Measured: May 2010
Secondary outcomes (1)
To evaluate immune responses using several defined assays as well as viral and CD4+ T cell status
Measured: May 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- French National Agency for Research on AIDS and Viral Hepatitis
- Responsible party
- Sponsor
- Investigators
- Jacques Banchereau, PhD, Principal investigator, Baylor Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796770
- Sponsor's protocol ID
- 008-017
- Status last verified
- Jun 2017
- First submitted
- 21 Nov 2008
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alexandre M, Prague M, Lhomme E, Lelievre JD, Wittkop L, Richert L, Levy Y, Thiebaut R. Definition of Virological Endpoints Improving the Design of HIV Cure Strategies Using Analytical Antiretroviral Treatment Interruption. Clin Infect Dis. 2024 Dec 17;79(6):1447-1457. doi: 10.1093/cid/ciae235.
PubMed 38819800Cobb A, Roberts LK, Palucka AK, Mead H, Montes M, Ranganathan R, Burkeholder S, Finholt JP, Blankenship D, King B, Sloan L, Harrod AC, Levy Y, Banchereau J. Development of a HIV-1 lipopeptide antigen pulsed therapeutic dendritic cell vaccine. J Immunol Methods. 2011 Feb 28;365(1-2):27-37. doi: 10.1016/j.jim.2010.11.002. Epub 2010 Nov 18.
PubMed 21093448
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination of HIV-1 Infected Patients With Ex-vivo Generated Interferon-α Dendritic Cells Loaded With HIV-1 Lipopeptides and Activated With Lipopolysaccharide in Addition to Antiretroviral Treatment: Exploratory Phase I Study-(DALIA Trial)
- ClinicalTrials.gov ID
- NCT00796770
- Acronym / sponsor ID
- 008-017
- Conditions
- HIV
- Keywords
- HIV, Vaccine, HAART, HIV-1, AIDS, Dendritic Cells, DALIA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- French National Agency for Research on AIDS and Viral Hepatitis
- Study start
- Nov 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 24 Nov 2008 (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 the administration of a dendritic cell vaccine is a safe and effective treatment for HIV-1 patients.
Detailed description
The purpose of this study is to determine whether the administration of a dendritic cell vaccine is a safe and effective treatment for HIV-1 patients. This will be a phase I, single-center, study in HIV infected patients. The primary objective is to evaluate safety of the vaccination schedule (from apheresis procedure to week 24) at week 24 and safety of the Analytical Treatment Interruption (ATI; from week 24 to week 48) at week 48 in HIV-1 infected patients who have been receiving antiretroviral therapy for at least 12 months with HIV-1 RNA ≤50 copies/mL and CD4+ T cell counts >500/mm3 at entry in the trial and who received, in addition to anti-retroviral therapy for 24 weeks, vaccination with ex vivo generated interferon-alpha dendritic cells loaded with HIV-1 lipopeptides and activated with lipopolysaccharide (BIIR/ANRS-HIVax-001, the DC vaccine product).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dendritic Cell Vaccine | Experimental | Biological: Dendritic Cell VaccineAutologous dendritic cells generated using GM-CSF and interferon alpha, loaded with HIV lipopeptides and activated with lipopolysaccharide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- ≥ 18 years old
- written informed consent
- HIV1 infection documented by any licensed ELISA test kit and confirmed by Western Blot at anytime prior to study entry
- on treatment with a combination of antiviral drugs (HAART) for at least 12 months, and stable on treatment for at least 3 months prior to enrollment. HAART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral drugs (other than 3 Nucs only and low dose ritonavir used for boosting other protease inhibitors does not count as one of these three antiretroviral agents)
- CD4+ T cell counts > 500 cells/mm3 on at least two consecutive measurements (including the screening value) within the previous 6 months prior to enrollment (occasional CD4 cell counts ranging between 450-500 cells/mm3 is permitted)
Key exclusion criteria (13 listed)
- Nadir CD4+ T cell counts < 300 cells/mm3 prior HAART
- pregnant or lactating woman
- any prior chemotherapy treatment
- interferon alpha (IFN-α-2b) or sargramostim (GM-CSF) < 12 weeks before the beginning of the trial
- interleukin-2 (IL-2) <12 weeks before the beginning of the trial,
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 |
|---|---|---|
| Dendritic Cell VaccineBiological/Vaccine: Experimental: Dendritic Cell Vaccine Patients will receive 4 doses of the vaccine at weeks 0, 4, 8 and 12. The vaccine will be injected subcutaneously, in 3 separate injection sites in the upper and lower extremities. At week 24, patients will have HAART treatment interrupted. The HAART treatment will be resumed at week 48 or earlier at any time point if one of the following occur: 1. two consecutive measurements of CD4+ T cell count below 350x10e6 cells/L and/or 25% of total lymphocytes within at least a 2 weeks 2. an opportunistic infection 3. a CDC class C-defining event (defined in appendix 2) 4. a serious non-AIDS defining event. Patients will have follow-up visits on weeks: 22, 24, 25, 26, 27, 28, 32, 36, 40, 44, and 48. | Biological | Dendritic Cell Vaccine |
Primary outcome
To evaluate the safety of the vaccination schedule at week 24 and the safety of the Analytical Treatment Interruption at week 48 in HIV-1 infected patients.
Time frame: May 2010
1 secondary outcome
To evaluate immune responses using several defined assays as well as viral and CD4+ T cell status
Time frame: May 2010
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 12 Jun 2017.
- Derived from this study: PubMed 38819800Alexandre M, Prague M, Lhomme E, Lelievre JD, Wittkop L, Richert L, Levy Y, Thiebaut R. Definition of Virological Endpoints Improving the Design of HIV Cure Strategies Using Analytical Antiretroviral Treatment Interruption. Clin Infect Dis. 2024 Dec 17;79(6):1447-1457. doi: 10.1093/cid/ciae235.
- Derived from this study: PubMed 21093448Cobb A, Roberts LK, Palucka AK, Mead H, Montes M, Ranganathan R, Burkeholder S, Finholt JP, Blankenship D, King B, Sloan L, Harrod AC, Levy Y, Banchereau J. Development of a HIV-1 lipopeptide antigen pulsed therapeutic dendritic cell vaccine. J Immunol Methods. 2011 Feb 28;365(1-2):27-37. doi: 10.1016/j.jim.2010.11.002. Epub 2010 Nov 18.
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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.
Jacques Banchereau, PhD principal investigator
Baylor Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dendritic Cell Vaccine in people with HIV, run by Baylor Research Institute at 1 site in United States.
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 16 inclusion and 13 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 12 Jun 2017. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To evaluate the safety of the vaccination schedule at week 24 and the safety of the Analytical Treatment Interruption at week 48 in HIV-1 infected patients. (time frame: May 2010). 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 NCT00796770, which also lists 2 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 12 Jun 2017.