HIV InfectionsPhase 1NCT00002353
A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects
A Phase 1 study testing P3C541b Lipopeptide in people with HIV Infections, run by United Biomedical at 1 site in United States.
Trial summary
To evaluate an HIV lipopeptide immunotherapeutic, P3C541b, at two dose levels administered subcutaneously in HIV-seropositive patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- P3C541b Lipopeptide
- How many people
- Not given
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have:
- HIV positivity.
- CD4 count >= 500 cells/mm3.
- No evidence of AIDS, persistent diarrhea, fever, oral hairy leukoplakia, herpes varicella-zoster (multidermatomal), oral candidiasis, opportunistic infections, severe cytomegalovirus infection, or disseminated or chronic herpes simplex.
- Successful establishment of EBV transformed B lymphoblastoid cell line.
- NOTE:
- Most patients in group 2 must possess one or more HLA types A33, B8, B27, or Bw62.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Active syphilis.
- Positive circulating hepatitis B virus antigen.
- Active clinically significant medical problems.
- Evidence of psychiatric, medical, or substance abuse problems that would affect ability to participate on study.
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- Occupational or other responsibilities that would prevent completion of study.
- Concurrent Medication:
- Excluded:
- Other HIV immunotherapeutic.
- Zidovudine or analog.
- Investigational therapies for HIV.
- Patients with the following prior conditions are excluded:
- History of cancer unless surgically excised with reasonable assurance of cure.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- History of serious allergic reaction to any substance that required hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasms, or hypotension).
- History of autoimmune disease or use of immunosuppressive medications.
- History of suicide attempts or past psychosis.
- Prior Medication:
- Excluded within the past 6 months:
- HIV immunotherapeutic.
- Zidovudine or analog.
- Investigational therapies for HIV. Illicit drug use within past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate an HIV lipopeptide immunotherapeutic, P3C541b, at two dose levels administered subcutaneously in HIV-seropositive patients.
Read the detailed description
Patients are randomized to receive P3C541b or placebo within each of two study groups. Enrollment in the first group will be independent of HLA type, whereas all but two of the patients enrolled in group 2 must have one or more HLA types A33, B8, B27, or Bw62. Treatment in group 2 will not begin until those in group 1 have reached day 14 without serious toxicity.
- Conditions
- HIV Infections
- Being tested
- P3C541b Lipopeptide
- Keywords
- Vaccines, Synthetic, AIDS Vaccines
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P3C541b LipopeptideBiological
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.
- 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
Sponsor and investigators
- Lead sponsor
- United Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002353
- Sponsor's protocol ID
- 090
- Other IDs
- V103B
- Status last verified
- Jul 1997
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects
- ClinicalTrials.gov ID
- NCT00002353
- Acronym / sponsor ID
- 090
- Conditions
- HIV Infections
- Keywords
- Vaccines, Synthetic, AIDS Vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- United BiomedicalIndustry (pharma, biotech, devices)
- 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.
To evaluate an HIV lipopeptide immunotherapeutic, P3C541b, at two dose levels administered subcutaneously in HIV-seropositive patients.
Detailed description
Patients are randomized to receive P3C541b or placebo within each of two study groups. Enrollment in the first group will be independent of HLA type, whereas all but two of the patients enrolled in group 2 must have one or more HLA types A33, B8, B27, or Bw62. Treatment in group 2 will not begin until those in group 1 have reached day 14 without serious toxicity.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- HIV positivity.
- CD4 count >= 500 cells/mm3.
- No evidence of AIDS, persistent diarrhea, fever, oral hairy leukoplakia, herpes varicella-zoster (multidermatomal), oral candidiasis, opportunistic infections, severe cytomegalovirus infection, or disseminated or chronic herpes simplex.
- Successful establishment of EBV transformed B lymphoblastoid cell line.
- Most patients in group 2 must possess one or more HLA types A33, B8, B27, or Bw62.
Key exclusion criteria (23 listed)
- Active syphilis.
- Positive circulating hepatitis B virus antigen.
- Active clinically significant medical problems.
- Evidence of psychiatric, medical, or substance abuse problems that would affect ability to participate on study.
- Occupational or other responsibilities that would prevent completion of study.
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 |
|---|---|---|
| P3C541b Lipopeptide | 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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 P3C541b Lipopeptide in people with HIV Infections, run by United Biomedical 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 7 inclusion and 23 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 24 Jun 2005. 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.
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 24 Jun 2005.