HIV InfectionsPhase 1NCT00052182
Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Infected Patients
A Phase 1 study testing EP HIV-1090 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
HIV-1-infected patients who have been treated with anti-HIV drugs for a long time may have weakened immune responses to HIV. The DNA-based vaccine in this study is designed to boost the immune system's responses against many HIV-1 proteins. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- EP HIV-1090
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to not given
- 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 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Documented HIV-1 infection
- Taking HAART for 6 months or longer and on stable HAART for at least 4 weeks
- Plasma HIV-1 viral load of less than 400 copies/ml for at least 6 months prior to study entry
- CD4 count of 350 cells/mm3 or more within 30 days of entry
Who cannot join
- Immunomodulatory agents
- Prior receipt of experimental HIV vaccines in the 5 years prior to study entry
- Hepatitis B surface antigen or hepatitis C virus antibody positive
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Health Science Center
Denver, Colorado, 80262
About this study
Official title: A Single Center Phase I Safety and Immunogenicity Study of Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) for Immunotherapy of HIV-1 Infected Individuals Receiving Highly Active Antiretroviral Therapy (HAART)
HIV-1-infected patients who have been treated with anti-HIV drugs for a long time may have weakened immune responses to HIV. The DNA-based vaccine in this study is designed to boost the immune system's responses against many HIV-1 proteins. The main purposes of this study are to test the safety of this HIV vaccine (EP HIV-1090) and to test whether the vaccine can stimulate immune system responses in people who have HIV-1 infection.
Read the detailed description
Significant data support the hypothesis that HIV-specific cytotoxic T lymphocyte (CTL) responses contribute to the control and potential clearance of the virus. Vaccines designed specifically to induce CTL responses are likely to be well suited for treatment of HIV infection. The conceptual basis of the EP HIV-1090 vaccine is the use of highly defined CTL epitopes as the vaccine immunogen. The vaccine is formulated with a water-soluble polymer that stabilizes and protects the DNA and facilitates uptake by cells. Preclinical studies have shown that the vaccine induces strong CTL responses in animal models. This study will evaluate the safety and tolerability of the vaccine and the immune response to the vaccine in HIV-1-infected individuals who are being treated with highly active antiretroviral therapy (HAART) and have a CD4 count of 350 cells/mm3 or more and fully suppressed viral replication on stable HAART.
Each patient will receive a total of four immunizations to be given at Day 0 and at Weeks 4, 8, and 16. Participants will be randomly assigned to receive either vaccine or placebo. Ten patients will be assigned to each dose group; eight will receive active vaccine and two will receive placebo. The injections will be delivered intramuscularly into the deltoid muscle. In addition to undergoing standard safety exams, patients will have blood drawn for use in evaluating the immunogenicity of the vaccine. The treatment duration will be 16 weeks and patient will be followed for safety and immune responses for an additional 24 weeks after they complete vaccination; the total study is estimated to take 18 months.
- Conditions
- HIV Infections
- Being tested
- EP HIV-1090
- Keywords
- HIV Therapeutic Vaccine, CTL Epitope, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP HIV-1090Biological
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Immunization on Day 0 and Weeks 4, 8, and 16 Receives: Biological: EP HIV-1090 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of four intramuscular doses of EP HIV-1090 to HIV infected participants using highly active antiretroviral therapy (HAART), who have a viral load less than 400
Measured: Throughout study
Secondary outcomes (3)
Peripheral blood CD8 T-cell (CTL) responses to vaccine, compared to placebo
Measured: Throughout study
CD4 T-cell count and viral load in patients continuing HAART following vaccination or receipt of placebo
Measured: Throughout study
Clinical signs and symptoms and development of AIDS-defining clinical events following vaccination or receipt of placebo in participants who remain on HAART
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Constance Benson, MD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052182
- Sponsor's protocol ID
- P01AI048238-03
- Other IDs
- IPCP 01
- Status last verified
- Sep 2007
- First submitted
- 24 Jan 2003
- Last updated
- 23 Oct 2007
- Results posted
- No
Publications
Wilson CC, McKinney D, Anders M, MaWhinney S, Forster J, Crimi C, Southwood S, Sette A, Chesnut R, Newman MJ, Livingston BD. Development of a DNA vaccine designed to induce cytotoxic T lymphocyte responses to multiple conserved epitopes in HIV-1. J Immunol. 2003 Nov 15;171(10):5611-23. doi: 10.4049/jimmunol.171.10.5611.
PubMed 14607970
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Phase I Safety and Immunogenicity Study of Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) for Immunotherapy of HIV-1 Infected Individuals Receiving Highly Active Antiretroviral Therapy (HAART)
- ClinicalTrials.gov ID
- NCT00052182
- Acronym / sponsor ID
- P01AI048238-03
- Conditions
- HIV Infections
- Keywords
- HIV Therapeutic Vaccine, CTL Epitope, Treatment Experienced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2002
- First posted
- 27 Jan 2003 (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.
HIV-1-infected patients who have been treated with anti-HIV drugs for a long time may have weakened immune responses to HIV. The DNA-based vaccine in this study is designed to boost the immune system's responses against many HIV-1 proteins. The main purposes of this study are to test the safety of this HIV vaccine (EP HIV-1090) and to test whether the vaccine can stimulate immune system responses in people who have HIV-1 infection.
Detailed description
Significant data support the hypothesis that HIV-specific cytotoxic T lymphocyte (CTL) responses contribute to the control and potential clearance of the virus. Vaccines designed specifically to induce CTL responses are likely to be well suited for treatment of HIV infection. The conceptual basis of the EP HIV-1090 vaccine is the use of highly defined CTL epitopes as the vaccine immunogen. The vaccine is formulated with a water-soluble polymer that stabilizes and protects the DNA and facilitates uptake by cells. Preclinical studies have shown that the vaccine induces strong CTL responses in animal models. This study will evaluate the safety and tolerability of the vaccine and the immune response to the vaccine in HIV-1-infected individuals who are being treated with highly active antiretroviral therapy (HAART) and have a CD4 count of 350 cells/mm3 or more and fully suppressed viral replication on stable HAART.
Each patient will receive a total of four immunizations to be given at Day 0 and at Weeks 4, 8, and 16. Participants will be randomly assigned to receive either vaccine or placebo. Ten patients will be assigned to each dose group; eight will receive active vaccine and two will receive placebo. The injections will be delivered intramuscularly into the deltoid muscle. In addition to undergoing standard safety exams, patients will have blood drawn for use in evaluating the immunogenicity of the vaccine. The treatment duration will be 16 weeks and patient will be followed for safety and immune responses for an additional 24 weeks after they complete vaccination; the total study is estimated to take 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: EP HIV-1090Immunization on Day 0 and Weeks 4, 8, and 16 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Documented HIV-1 infection
- Taking HAART for 6 months or longer and on stable HAART for at least 4 weeks
- Plasma HIV-1 viral load of less than 400 copies/ml for at least 6 months prior to study entry
- CD4 count of 350 cells/mm3 or more within 30 days of entry
Key exclusion criteria (3 listed)
- Immunomodulatory agents
- Prior receipt of experimental HIV vaccines in the 5 years prior to study entry
- Hepatitis B surface antigen or hepatitis C virus antibody positive
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 |
|---|---|---|
| EP HIV-1090 | Biological | 1 |
Primary outcome
Safety and efficacy of four intramuscular doses of EP HIV-1090 to HIV infected participants using highly active antiretroviral therapy (HAART), who have a viral load less than 400
Time frame: Throughout study
3 secondary outcomes
Peripheral blood CD8 T-cell (CTL) responses to vaccine, compared to placebo
Time frame: Throughout study
CD4 T-cell count and viral load in patients continuing HAART following vaccination or receipt of placebo
Time frame: Throughout study
Clinical signs and symptoms and development of AIDS-defining clinical events following vaccination or receipt of placebo in participants who remain on HAART
Time frame: Throughout 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 23 Oct 2007.
- Background: PubMed 14607970Wilson CC, McKinney D, Anders M, MaWhinney S, Forster J, Crimi C, Southwood S, Sette A, Chesnut R, Newman MJ, Livingston BD. Development of a DNA vaccine designed to induce cytotoxic T lymphocyte responses to multiple conserved epitopes in HIV-1. J Immunol. 2003 Nov 15;171(10):5611-23. doi: 10.4049/jimmunol.171.10.5611.
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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.
Constance Benson, MD study chair
University of California, San Diego
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 EP HIV-1090 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 4 inclusion and 3 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 23 Oct 2007. 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?
Safety and efficacy of four intramuscular doses of EP HIV-1090 to HIV infected participants using highly active antiretroviral therapy (HAART), who have a viral load less than 400 (time frame: Throughout study). 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 NCT00052182, 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 23 Oct 2007.