HIV InfectionsPhase 2NCT00021762
Effects of Immunization With HIV-1 Immunogen Plus Anti-HIV Treatment Interruption on the Levels of HIV
A Phase 2 study testing HIV-1 Immunogen and Structured Treatment Interruption in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
The purpose of this study is to see whether or not an HIV vaccination will help the body control the amount of HIV virus in blood (viral load) in patients who are not taking anti-HIV medicines. Doctors are not sure why the body fails to control HIV viral load in most people infected with HIV. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections
- What is being tested?
- HIV-1 Immunogen and Structured Treatment Interruption
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Have been enrolled in A5057, which includes the 6-month extension.
- Have participated in A5057 for at least 44 weeks.
- Received at least 4 treatments on A5057.
- Are between 8 and 22 weeks from the last study injection on A5057.
- Have a viral load (amount of HIV in the blood) of 400 or less copies/ml at screening.
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- Have a stable anti-HIV drug combination (no changes in anti-HIV drugs) for 8 or more weeks prior to entry.
- Have a CD4 count of 300 or more cells/ml at screening.
- Agree to use at least 1 approved method of birth control, if women able to have children. Birth control is not required if a male partner is infertile and provides evidence of that fact.
- Have a negative pregnancy test within 14 days of study entry.
Who cannot join
- Patients will not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Are allergic to the study drugs.
- Have had an acute infection requiring an antibiotic, an outbreak of herpes simplex virus or herpes zoster, or other acute medical illness or surgery within 30 days prior to screening.
- Have received within 30 days of study entry GM-CSF, G-CSF, M-CSF, IFN, IL-2, or other cytokines; drugs affecting the immune system including cyclosporine, methotrexate, azathioprine, anti-CD25 antibody, or other agents; systemic oral or IV corticosteroids for 21 or more days; and HIV vaccine other than the one provided in this study; hydroxyurea; systemic cytotoxic chemotherapy; or medications that should not be taken with any HIV drugs being received.
- Have been assigned randomly to A5058s.
About this study
Official title: A Pilot Phase II Evaluation of the Effects on HIV Replication of Immunization With a gp120-Depleted, Inactivated Whole Virus Vaccine Combined With Exposures to Replicating Autologous HIV by Scheduled Treatment Interruptions, a Rollover Study of A5057
The purpose of this study is to see whether or not an HIV vaccination will help the body control the amount of HIV virus in blood (viral load) in patients who are not taking anti-HIV medicines.
Doctors are not sure why the body fails to control HIV viral load in most people infected with HIV. The vaccine Remune has been shown to boost part of the body's immune response to HIV in patients whose viral load has been lowered with anti-HIV drugs. This study will test the ability of Remune to improve the body's immune response and to lower HIV viral load in patients who stop taking anti-HIV drugs for short periods of time.
Read the detailed description
Investigators of the pathogenesis of HIV infection agree that one of the most critical questions in HIV disease is why immune responses do not control HIV replication in the vast majority of infected individuals. More specifically, the absence of large lymphocyte proliferation response (LPR) to HIV antigens in these individuals, and their presence in long-term nonprogressors (LTNPs) with a low viral load, requires an investigation of whether a causal relationship exists between LPR to HIV and control of HIV replication. Immunization with Remune has been shown to induce large LPR to HIV antigens when administered to patients in whom HIV replication has been suppressed with antiretroviral therapy (ART). A5120 will evaluate the abilities of immunization with HIV-1 Immunogen and of STIs to enhance immune responses that may control HIV replication in the absence of antiretroviral drugs.
Patients remain in the treatment arm (vaccine versus adjuvant placebo) to which they were randomized on entry to protocol A5057, and both the participant and investigator remain blinded as to the assignment. Patients may receive up to 3 injections of vaccine/adjuvant control in 1 of the following 2 groups.
Arm A: HIV-1 immunogen at study entry and at Week 9 in Step 3 and Step 5. Arm B: HIV-1 immunogen placebo at study entry and at Week 9 in Step 3 and Step 5.
ART is required during Steps 1, 3, 5, and 8 but is not provided by this study. The study is organized into the following series of steps.
Step 1 (ART and injection): receive injection of vaccine/adjuvant control. Patients remain on ART for 6 to 8 weeks.
Step 2 (first STI): all ART is stopped for up to 8 weeks with careful monitoring of viral load and CD4 T cells. Patients whose viral load is controlled may remain on Step 2 for an additional 6 weeks.
Step 3 (resumption of ART): restart ART for 14 weeks. Eligible patients receive an immunization with vaccine/adjuvant control at Week 9.
Step 4 (second STI): identical to Step 2. Step 5 (resumption of ART): identical to Step 3. Step 6 (analytical treatment interruption [ATI]): analytical "read-out" discontinuation of ART for up to 14 weeks.
Step 7 (long-term follow-up without ART): open only to patients with control of viral load who agree to participate in continued treatment withdrawal.
Step 8 (final resumption of ART): patients are followed for 8 weeks on ART to document the effect of restarting ART on suppression of viral load. Patients advance through steps as criteria for HIV RNA level, CD4 count, and treatment are met.
Patients have regular clinic visits for medical/medication histories, physical examinations, and laboratory tests for viral load and immunological parameters.
- Conditions
- HIV Infections
- Being tested
- HIV-1 Immunogen, Structured Treatment Interruption
- Keywords
- Virus Replication, HIV-1, Drug Administration Schedule, AIDS Vaccines, RNA, Viral, Viral Load, HIV-1 immunogen, incomplete Freund's adjuvant, Treatment Interruption, 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.
HIV-1 ImmunogenBiological
Structured Treatment InterruptionProcedure or surgery
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)
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 2
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Fred Valentine, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021762
- Sponsor's protocol ID
- A5120
- Other IDs
- 10938, ACTG A5120, AACTG A5120
- Status last verified
- Oct 2021
- First submitted
- 4 Aug 2001
- 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
- A Pilot Phase II Evaluation of the Effects on HIV Replication of Immunization With a gp120-Depleted, Inactivated Whole Virus Vaccine Combined With Exposures to Replicating Autologous HIV by Scheduled Treatment Interruptions, a Rollover Study of A5057
- ClinicalTrials.gov ID
- NCT00021762
- Acronym / sponsor ID
- A5120
- Conditions
- HIV Infections
- Keywords
- Virus Replication, HIV-1, Drug Administration Schedule, AIDS Vaccines, RNA, Viral, Viral Load, HIV-1 immunogen, incomplete Freund's adjuvant, Treatment Interruption
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- 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 whether or not an HIV vaccination will help the body control the amount of HIV virus in blood (viral load) in patients who are not taking anti-HIV medicines.
Doctors are not sure why the body fails to control HIV viral load in most people infected with HIV. The vaccine Remune has been shown to boost part of the body's immune response to HIV in patients whose viral load has been lowered with anti-HIV drugs. This study will test the ability of Remune to improve the body's immune response and to lower HIV viral load in patients who stop taking anti-HIV drugs for short periods of time.
Detailed description
Investigators of the pathogenesis of HIV infection agree that one of the most critical questions in HIV disease is why immune responses do not control HIV replication in the vast majority of infected individuals. More specifically, the absence of large lymphocyte proliferation response (LPR) to HIV antigens in these individuals, and their presence in long-term nonprogressors (LTNPs) with a low viral load, requires an investigation of whether a causal relationship exists between LPR to HIV and control of HIV replication. Immunization with Remune has been shown to induce large LPR to HIV antigens when administered to patients in whom HIV replication has been suppressed with antiretroviral therapy (ART). A5120 will evaluate the abilities of immunization with HIV-1 Immunogen and of STIs to enhance immune responses that may control HIV replication in the absence of antiretroviral drugs.
Patients remain in the treatment arm (vaccine versus adjuvant placebo) to which they were randomized on entry to protocol A5057, and both the participant and investigator remain blinded as to the assignment. Patients may receive up to 3 injections of vaccine/adjuvant control in 1 of the following 2 groups.
Arm A: HIV-1 immunogen at study entry and at Week 9 in Step 3 and Step 5. Arm B: HIV-1 immunogen placebo at study entry and at Week 9 in Step 3 and Step 5.
ART is required during Steps 1, 3, 5, and 8 but is not provided by this study. The study is organized into the following series of steps.
Step 1 (ART and injection): receive injection of vaccine/adjuvant control. Patients remain on ART for 6 to 8 weeks.
Step 2 (first STI): all ART is stopped for up to 8 weeks with careful monitoring of viral load and CD4 T cells. Patients whose viral load is controlled may remain on Step 2 for an additional 6 weeks.
Step 3 (resumption of ART): restart ART for 14 weeks. Eligible patients receive an immunization with vaccine/adjuvant control at Week 9.
Step 4 (second STI): identical to Step 2. Step 5 (resumption of ART): identical to Step 3. Step 6 (analytical treatment interruption [ATI]): analytical "read-out" discontinuation of ART for up to 14 weeks.
Step 7 (long-term follow-up without ART): open only to patients with control of viral load who agree to participate in continued treatment withdrawal.
Step 8 (final resumption of ART): patients are followed for 8 weeks on ART to document the effect of restarting ART on suppression of viral load. Patients advance through steps as criteria for HIV RNA level, CD4 count, and treatment are met.
Patients have regular clinic visits for medical/medication histories, physical examinations, and laboratory tests for viral load and immunological parameters.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Have been enrolled in A5057, which includes the 6-month extension.
- Have participated in A5057 for at least 44 weeks.
- Received at least 4 treatments on A5057.
- Are between 8 and 22 weeks from the last study injection on A5057.
- Have a viral load (amount of HIV in the blood) of 400 or less copies/ml at screening.
Key exclusion criteria (6 listed)
- Are pregnant or breast-feeding.
- Are allergic to the study drugs.
- Have had an acute infection requiring an antibiotic, an outbreak of herpes simplex virus or herpes zoster, or other acute medical illness or surgery within 30 days prior to screening.
- Have received within 30 days of study entry GM-CSF, G-CSF, M-CSF, IFN, IL-2, or other cytokines; drugs affecting the immune system including cyclosporine, methotrexate, azathioprine, anti-CD25 antibody, or other agents; systemic oral or IV corticosteroids for 21 or more days; and HIV vaccine other than the one provided in this study; hydroxyurea; systemic cytotoxic chemotherapy; or medications that should not be taken with any HIV drugs being received.
- Have been assigned randomly to A5058s.
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 |
|---|---|---|
| HIV-1 Immunogen | Biological | – |
| Structured Treatment Interruption | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Fred Valentine study chair
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HIV-1 Immunogen and Structured Treatment Interruption in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
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 10 inclusion and 6 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: withdrawn, 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.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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.