HIV InfectionsPhase 1NCT00006153
Effectiveness of Adding Remune to Your Current Anti-HIV Drug Combination
A Phase 1 study testing HIV-1 Immunogen in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to see if giving a vaccine (Remune) is effective in HIV-positive patients who are also taking anti-HIV therapy. Regular treatment of HIV-positive patients with anti-HIV drugs slows the multiplication of the HIV virus in the body. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- HIV-1 Immunogen
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of HIV.
- Have been on an anti-HIV drug combination that includes a protease inhibitor for at least 3 months but no longer than 12 months.
- Have 2 consecutive viral loads of less than 50 copies/ml, at least 30 days apart, within 90 days of study entry.
- Are at least 16 years old (consent of parent or guardian required if under 18 years).
- Agree to practice abstinence or use effective methods of birth control during the study.
Who cannot join
- Patients will not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Currently abuse alcohol or drugs.
- Are currently being treated for some types of cancer.
- Have any illness or condition that might interfere with the study or put them at risk.
- Have received a vaccination 6 weeks before study entry.
- Have previously received Remune.
- Are taking medications that affect the immune system within 30 days of study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-Blind, Phase I, Adjuvant Controlled Study to Evaluate the Effect of Remune (HIV-1 Immunogen) Compared to IFA, in Combination With Fully Suppressive Antiviral Drug Therapy on HIV-1-Specific Immunogenicity in Subjects With Acute or Primary HIV-1 Infection
The purpose of this study is to see if giving a vaccine (Remune) is effective in HIV-positive patients who are also taking anti-HIV therapy.
Regular treatment of HIV-positive patients with anti-HIV drugs slows the multiplication of the HIV virus in the body. A vaccine called Remune works to stop the virus infection by "boosting" the body's immune cell defense against the HIV virus before the virus enters cells. It also blocks the virus from entering the cells. This study will see whether Remune will improve the immune cell natural defense in patients who are also taking anti-HIV drugs.
Read the detailed description
During primary HIV infection, after an initial burst in viral load, the body mounts an immunologic response to viral antigens. It is thought that this initial immune response plays an important role in determining early and long-term suppression of HIV. However, limited information is available regarding the effect of early antiretroviral therapy on immune responses. Therapeutic approaches such as Remune, which augment cell-mediated immunologic responses, may prove to be beneficial in controlling the progression of HIV infection, especially when used in combination with antiretroviral therapy in early infection. Current antiviral drugs work by inhibiting the infection of new cells yet seem to suppress early cell-mediated immune responses. The question is raised as to whether immune-based therapies such as Remune may counteract the suppressive effects of antiretrovirals and slow the progression of infection.
Patients receiving fully suppressive antiretroviral therapy are randomized to add either Remune or an Incomplete Freund's Adjuvant (IFA) control. Vaccinations are administered on Day 1, Week 12, and Week 24. Blood samples are collected at Day 1 and Weeks 4, 12, 16, 24, and 28. Clinical assessment includes lymphocyte proliferative response, cytotoxic T lymphocyte (CTL) memory cell activity, chemokine and cytokine measurements, CD4 count, and viral load. Delayed-type hypersensitivity (DTH) skin tests are performed at Day 1 and Week 28. HIV-1 specific immunogenicity is coordinated with the response to antiretroviral therapy in patients.
- Conditions
- HIV Infections
- Being tested
- HIV-1 Immunogen
- Keywords
- HIV Antibodies, Immunity, Cellular, Drug Therapy, Combination, Anti-HIV Agents, remune, 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
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 1
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 45 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- The Immune Response Corporation
- Investigators
- Eric Daar, Principal investigatorSusan Little, Principal investigatorJanis Giorgi, Principal investigatorRachel Schrier, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006153
- Sponsor's protocol ID
- AIEDRP AI-05-006
- Other IDs
- 905
- Status last verified
- Jun 2003
- First submitted
- 7 Aug 2000
- Last updated
- 30 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Phase I, Adjuvant Controlled Study to Evaluate the Effect of Remune (HIV-1 Immunogen) Compared to IFA, in Combination With Fully Suppressive Antiviral Drug Therapy on HIV-1-Specific Immunogenicity in Subjects With Acute or Primary HIV-1 Infection
- ClinicalTrials.gov ID
- NCT00006153
- Acronym / sponsor ID
- AIEDRP AI-05-006
- Conditions
- HIV Infections
- Keywords
- HIV Antibodies, Immunity, Cellular, Drug Therapy, Combination, Anti-HIV Agents, remune, HIV Therapeutic Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 45 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- The Immune Response Corporation
- 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 if giving a vaccine (Remune) is effective in HIV-positive patients who are also taking anti-HIV therapy.
Regular treatment of HIV-positive patients with anti-HIV drugs slows the multiplication of the HIV virus in the body. A vaccine called Remune works to stop the virus infection by "boosting" the body's immune cell defense against the HIV virus before the virus enters cells. It also blocks the virus from entering the cells. This study will see whether Remune will improve the immune cell natural defense in patients who are also taking anti-HIV drugs.
Detailed description
During primary HIV infection, after an initial burst in viral load, the body mounts an immunologic response to viral antigens. It is thought that this initial immune response plays an important role in determining early and long-term suppression of HIV. However, limited information is available regarding the effect of early antiretroviral therapy on immune responses. Therapeutic approaches such as Remune, which augment cell-mediated immunologic responses, may prove to be beneficial in controlling the progression of HIV infection, especially when used in combination with antiretroviral therapy in early infection. Current antiviral drugs work by inhibiting the infection of new cells yet seem to suppress early cell-mediated immune responses. The question is raised as to whether immune-based therapies such as Remune may counteract the suppressive effects of antiretrovirals and slow the progression of infection.
Patients receiving fully suppressive antiretroviral therapy are randomized to add either Remune or an Incomplete Freund's Adjuvant (IFA) control. Vaccinations are administered on Day 1, Week 12, and Week 24. Blood samples are collected at Day 1 and Weeks 4, 12, 16, 24, and 28. Clinical assessment includes lymphocyte proliferative response, cytotoxic T lymphocyte (CTL) memory cell activity, chemokine and cytokine measurements, CD4 count, and viral load. Delayed-type hypersensitivity (DTH) skin tests are performed at Day 1 and Week 28. HIV-1 specific immunogenicity is coordinated with the response to antiretroviral therapy in patients.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of HIV.
- Have been on an anti-HIV drug combination that includes a protease inhibitor for at least 3 months but no longer than 12 months.
- Have 2 consecutive viral loads of less than 50 copies/ml, at least 30 days apart, within 90 days of study entry.
- Are at least 16 years old (consent of parent or guardian required if under 18 years).
- Agree to practice abstinence or use effective methods of birth control during the study.
Key exclusion criteria (8 listed)
- Are pregnant or breast-feeding.
- Currently abuse alcohol or drugs.
- Are currently being treated for some types of cancer.
- Have any illness or condition that might interfere with the study or put them at risk.
- Have received a vaccination 6 weeks before study entry.
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 | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2008.
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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.
Eric Daar principal investigator
Susan Little principal investigator
Janis Giorgi principal investigator
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 HIV-1 Immunogen 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 30 Jul 2008. 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 was stopped early. Results are not available in the source record.
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 30 Jul 2008.