HIV InfectionsPhase 1NCT00195234
Study Evaluating Vaccine in Adults With HIV
A Phase 1 study testing HIV CTL MEP 1000 micrograms, 19 months per subject in people with HIV Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 10 sites in United States.
Trial summary
The purpose of this study is to learn whether the study vaccine and adjuvants (drugs that are used to help improve immune responses) have an acceptable safety profile in treating individuals with HIV. A second purpose of this study is to understand how the immune system responds to the study vaccine and adjuvants. 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?
- HIV CTL MEP 1000 micrograms, 19 months per subject
- How many people
- 60 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2004to Feb 2007
- 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 of age diagnosed with HIV and on stable HAART for a minimum of six months
- CD4 T-cell count greater than and equal to 350/mm3 at screening
- No reported CD4 T-cell count less than 350/mm3 at any time before screening
- Viral load less than 50 copies/mL at screening and no viral load greater than 400 copies/mL for a minimum of six months prior to screening
Who cannot join
- Any chronic symptomatic infection other than HIV
- Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening
- Any malignancy that may require systemic therapy
- Use of any investigational treatment within six months before screening or planned during study enrollment, except for investigational retrovirals obtained through ACTG
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Austin, Texas, 78705
Study site
Chicago, Illinois, 60612
Study site
Cleveland, Ohio, 44106-5083
Study site
Dallas, Texas, 75246
Study site
Dallas, Texas, 75390-9103
Study site
Denver, Colorado, 80262
Study site
Nashville, Tennessee, 37232-2582
Study site
New York, New York, 10003
Study site
Philadelphia, Pennsylvania, 19104
Study site
Sacramento, California, 95817
About this study
Official title: A Phase 1 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of an HIV CTL Multi-Epitope Peptide Vaccine Formulated With RC529-SE and GM-CSF Given to HIV-1 Positive Adults on Stable HAART.
The purpose of this study is to learn whether the study vaccine and adjuvants (drugs that are used to help improve immune responses) have an acceptable safety profile in treating individuals with HIV.
A second purpose of this study is to understand how the immune system responds to the study vaccine and adjuvants.
- Conditions
- HIV Infections
- Being tested
- HIV CTL MEP 1000 micrograms, 19 months per subject
- Keywords
- HIV, 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.
HIV CTL MEP 1000 micrograms, 19 months per subjectBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of the HIV CTL MEP vaccine formulated with adjuvants, administered by intramuscular (IM) injection to HIV Pos adults receiving stable HAART. Subjects will receive vaccinations at months 0, 1, 3, and 6.
Secondary outcomes (1)
To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startDec 2004
- Study completionFeb 2007
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.
- 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195234
- Sponsor's protocol ID
- 6112K2-100
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 5 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of an HIV CTL Multi-Epitope Peptide Vaccine Formulated With RC529-SE and GM-CSF Given to HIV-1 Positive Adults on Stable HAART.
- ClinicalTrials.gov ID
- NCT00195234
- Acronym / sponsor ID
- 6112K2-100
- Conditions
- HIV Infections
- Keywords
- HIV, Treatment Experienced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Feb 2007 (actual)
- First posted
- 19 Sep 2005 (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 learn whether the study vaccine and adjuvants (drugs that are used to help improve immune responses) have an acceptable safety profile in treating individuals with HIV.
A second purpose of this study is to understand how the immune system responds to the study vaccine and adjuvants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (4 listed)
- 18 years of age diagnosed with HIV and on stable HAART for a minimum of six months
- CD4 T-cell count greater than and equal to 350/mm3 at screening
- No reported CD4 T-cell count less than 350/mm3 at any time before screening
- Viral load less than 50 copies/mL at screening and no viral load greater than 400 copies/mL for a minimum of six months prior to screening
Key exclusion criteria (4 listed)
- Any chronic symptomatic infection other than HIV
- Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening
- Any malignancy that may require systemic therapy
- Use of any investigational treatment within six months before screening or planned during study enrollment, except for investigational retrovirals obtained through ACTG
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 CTL MEP 1000 micrograms, 19 months per subject | Biological | – |
Primary outcome
To evaluate the safety and tolerability of the HIV CTL MEP vaccine formulated with adjuvants, administered by intramuscular (IM) injection to HIV Pos adults receiving stable HAART. Subjects will receive vaccinations at months 0, 1, 3, and 6.
1 secondary outcome
To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination.
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 5 Dec 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
10 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 HIV CTL MEP 1000 micrograms, 19 months per subject in people with HIV Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 10 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 4 inclusion and 4 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 5 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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.
What does the primary outcome measure?
To evaluate the safety and tolerability of the HIV CTL MEP vaccine formulated with adjuvants, administered by intramuscular (IM) injection to HIV Pos adults receiving stable HAART. Subjects will receive vaccinations at months 0, 1, 3, and 6.. It is what the study was designed to measure, not a finding.
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 5 Dec 2007.