HIV InfectionsPhase 1NCT00006495
Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452
A Phase 1 study testing ALVAC(2)120(B,MN)GNP (vCP1452) and HIV-1 Immunogen in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.
Trial summary
The purpose of this study is to see how the vaccines Remune (HIV-1 immunogen) and vCP1452 affect immune responses in patients who also are taking anti-HIV medications. This study also will see if these vaccines are safe to use either alone or in combination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- ALVAC(2)120(B,MN)GNP (vCP1452) and HIV-1 Immunogen
- How many people
- 80 participants
- Where
- 9 sitesUnited States
- Study dates
- Start not givento Sep 2004
- 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
- Patients may be eligible for Step I of this study if they:
- Are at least 18 years old.
- Are HIV-infected.
- Have been on stable anti-HIV combination drug therapy for at least 12 weeks prior to screening for viral load and are willing to continue the same treatment during the study unless they experience side effects from the drugs and have a viral load increase.
- Have a viral load lower than 50 copies/ml at screening. Patients must have had a viral load below 500 copies/ml for at least 12 weeks prior to screening.
- Have a CD4 T cell count of at least 300 cells/mm3 within 30 days prior to study entry.
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- Agree to practice acceptable methods of birth control, including male and female condoms, a diaphragm, or an intra-uterine device (IUD), while on study treatment and for 12 weeks after study treatment is discontinued.
- Patients may be eligible for Step II of this study if they:
- Are enrolled in A5058s under A5057/A5058s, Versions 1.0 and 2.0.
Who cannot join
- Patients will not be eligible for Step I of this study if they:
- Are pregnant or breast-feeding.
- Have an acute infection requiring antibiotics, an outbreak of a herpes virus, or other illness or surgery within 30 days prior to entry.
- Have a long-term infection other than HIV.
- Have cancer that may require systemic treatment.
- Have had lymph node irradiation.
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- Have received any HIV vaccine.
- Have used GM-CSF, G-CSF, M-CSF, IFN, IL-2, or similar medication within 30 days prior to entry.
- Have used drugs affecting the immune system within 30 days prior to entry, or have an illness that may require use of these drugs.
- Have had immunizations within 30 days prior to study entry.
- Have received hydroxyurea within 30 days prior to study entry.
- Are allergic to egg proteins or neomycin or have had other serious allergic reactions.
- Work in close contact with canaries, or react to canarypox. Persons with a pet canary are not excluded.
- Have had 2 viral load measurements in a row taken at least 14 days apart that were 500 copies/ml or higher in the 12 weeks prior to screening.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215
Unc Aids Crs
Chapel Hill, North Carolina, 275997215
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, 775550435
UCLA CARE Center CRS
Los Angeles, California, 90095
Univ. of Miami AIDS CRS
Miami, Florida, 331361013
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
About this study
Official title: Augmentation of HIV-Specific Helper and CTL Responses Through Therapeutic Vaccination in Individuals Receiving Potent Suppressive Antiretroviral Therapies
The purpose of this study is to see how the vaccines Remune (HIV-1 immunogen) and vCP1452 affect immune responses in patients who also are taking anti-HIV medications. This study also will see if these vaccines are safe to use either alone or in combination.
Treatment with anti-HIV drugs does not always keep HIV viral load low and under control. This study will look at the effect of the HIV vaccine, vCP1452, on the immune response and how it works in combination with Remune. Information about immune responses and the safety of these vaccines in HIV-positive patients will be gathered.
Read the detailed description
Human viral infections are controlled by the immune system. However, the multiple immune responses provoked by HIV infection do not control the infection in most people. The ability to specifically augment CTL responses with an immunotherapeutic vaccine may strengthen the containment of viremia afforded by antiretroviral agents and thereby extend the durability of viral suppression. The current study will attempt to determine whether therapeutic immunizations with HIV-1 immunogen and vCP1452 are safe and able to augment HIV-1 specific immune responses for a longer period of time than antiretroviral therapy alone, and if both agents are better than either by itself.
Patients currently enrolled in A5058s under A5057/A5058s Versions 1.0 and 2.0 will be given the option of continuing their participation in A5058s through this independent study. Rollover patients register to Step II and begin treatment/evaluations on A5058s at the same study week that they were on in Versions 1.0 and 2.0 of A5057/A5058s. New patients enter Step I and will not need to register to Step II. Step I patients are stratified on the basis of HIV viral load, antiretroviral history, and current antiretroviral treatment. Within each stratum, patients are randomized to 1 of the following 4 treatment arms: HIV-1 immunogen plus ALVAC placebo, HIV-1 immunogen placebo plus ALVAC placebo, HIV-1 immunogen placebo plus vCP1452, or HIV-1 immunogen plus vCP1452. Patients receive an injection at study entry and every 12 weeks thereafter until the end of the study, a minimum of 2 years. Step II patients receive the same treatment as patients in Step I. Patients are evaluated every 12 weeks for clinical, immunologic, and virologic parameters. Patients continue taking the antiretroviral treatment that they were taking at study entry until reaching a virologic relapse as defined in the protocol. If no response to a new drug regimen occurs, or the antiretroviral therapy is not changed, immunizations may continue as long as the viral load remains below 5,000 copies/ml.
- Conditions
- HIV Infections
- Being tested
- ALVAC(2)120(B,MN)GNP (vCP1452), HIV-1 Immunogen
- Keywords
- Placebos, T-Lymphocytes, Helper-Inducer, AIDS Vaccines, RNA, Viral, HIV Core Protein p24, T-Lymphocytes, Cytotoxic, Anti-HIV Agents, HIV Therapeutic Vaccine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALVAC(2)120(B,MN)GNP (vCP1452)Biological
HIV-1 ImmunogenBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Spyros Kalams, Study chairFred Valentine, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006495
- Sponsor's protocol ID
- A5058s
- Other IDs
- 10674, ACTG A5058s, AACTG A5058s
- Status last verified
- Oct 2021
- First submitted
- 15 Nov 2000
- Last updated
- 1 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of HIV-Specific Helper and CTL Responses Through Therapeutic Vaccination in Individuals Receiving Potent Suppressive Antiretroviral Therapies
- ClinicalTrials.gov ID
- NCT00006495
- Acronym / sponsor ID
- A5058s
- Conditions
- HIV Infections
- Keywords
- Placebos, T-Lymphocytes, Helper-Inducer, AIDS Vaccines, RNA, Viral, HIV Core Protein p24, T-Lymphocytes, Cytotoxic, Anti-HIV Agents, HIV Therapeutic Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Sep 2004 (actual)
- First posted
- 31 Aug 2001 (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 see how the vaccines Remune (HIV-1 immunogen) and vCP1452 affect immune responses in patients who also are taking anti-HIV medications. This study also will see if these vaccines are safe to use either alone or in combination.
Treatment with anti-HIV drugs does not always keep HIV viral load low and under control. This study will look at the effect of the HIV vaccine, vCP1452, on the immune response and how it works in combination with Remune. Information about immune responses and the safety of these vaccines in HIV-positive patients will be gathered.
Detailed description
Human viral infections are controlled by the immune system. However, the multiple immune responses provoked by HIV infection do not control the infection in most people. The ability to specifically augment CTL responses with an immunotherapeutic vaccine may strengthen the containment of viremia afforded by antiretroviral agents and thereby extend the durability of viral suppression. The current study will attempt to determine whether therapeutic immunizations with HIV-1 immunogen and vCP1452 are safe and able to augment HIV-1 specific immune responses for a longer period of time than antiretroviral therapy alone, and if both agents are better than either by itself.
Patients currently enrolled in A5058s under A5057/A5058s Versions 1.0 and 2.0 will be given the option of continuing their participation in A5058s through this independent study. Rollover patients register to Step II and begin treatment/evaluations on A5058s at the same study week that they were on in Versions 1.0 and 2.0 of A5057/A5058s. New patients enter Step I and will not need to register to Step II. Step I patients are stratified on the basis of HIV viral load, antiretroviral history, and current antiretroviral treatment. Within each stratum, patients are randomized to 1 of the following 4 treatment arms: HIV-1 immunogen plus ALVAC placebo, HIV-1 immunogen placebo plus ALVAC placebo, HIV-1 immunogen placebo plus vCP1452, or HIV-1 immunogen plus vCP1452. Patients receive an injection at study entry and every 12 weeks thereafter until the end of the study, a minimum of 2 years. Step II patients receive the same treatment as patients in Step I. Patients are evaluated every 12 weeks for clinical, immunologic, and virologic parameters. Patients continue taking the antiretroviral treatment that they were taking at study entry until reaching a virologic relapse as defined in the protocol. If no response to a new drug regimen occurs, or the antiretroviral therapy is not changed, immunizations may continue as long as the viral load remains below 5,000 copies/ml.
Study design
- Primary purpose
- Treatment
- 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 (9 listed)
- Are at least 18 years old.
- Are HIV-infected.
- Have been on stable anti-HIV combination drug therapy for at least 12 weeks prior to screening for viral load and are willing to continue the same treatment during the study unless they experience side effects from the drugs and have a viral load increase.
- Have a viral load lower than 50 copies/ml at screening. Patients must have had a viral load below 500 copies/ml for at least 12 weeks prior to screening.
- Have a CD4 T cell count of at least 300 cells/mm3 within 30 days prior to study entry.
Key exclusion criteria (14 listed)
- Are pregnant or breast-feeding.
- Have an acute infection requiring antibiotics, an outbreak of a herpes virus, or other illness or surgery within 30 days prior to entry.
- Have a long-term infection other than HIV.
- Have cancer that may require systemic treatment.
- Have had lymph node irradiation.
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 |
|---|---|---|
| ALVAC(2)120(B,MN)GNP (vCP1452) | Biological | – |
| HIV-1 Immunogen | Biological | – |
Primary outcome
Not reported in the source record.
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 1 Nov 2021.
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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.
Spyros Kalams study chair
Fred Valentine study chair
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALVAC(2)120(B,MN)GNP (vCP1452) and HIV-1 Immunogen in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites 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 9 inclusion and 14 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
Where can I read the original study information?
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 1 Nov 2021.