Acquired Immunodeficiency SyndromePhase 1NCT00001386
Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With Synthetic HIV Envelope Peptides in Patients With Early Human Immunodeficiency Virus Infection
A Phase 1 study testing PCLUS 3-18 MN and PCLUS 6.1 MN in people with Acquired Immunodeficiency Syndrome and HIV Infection, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Synthetic HIV Peptide Vaccines (Treatment Protocol) We are conducting a study to evaluate the safety of two peptide vaccines (given alone or in combination) in patients with early HIV infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, HIV Infection
- What is being tested?
- PCLUS 3-18 MN and PCLUS 6.1 MN
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1994to Jan 2002
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Patients who are seropositive, documented by a licensed ELISA with a confirmatory Western blot assay for HIV with greater than or equal to 500 CD4+ cells/mm(3) at the time of screening who also meet either of the 2 following criteria:
During acute infection there is no lower limit for the CD4 count (acute infection is defined for this protocol as the 6 month period after diagnosis of HIV seropositivity in a patient with documented negative HIV serology within the 6 months prior to diagnosis of HIV seropositivity) OR;
If there is a history of CD4 count less than 300 cells/mm(s) at any point after initial HIV seropositive diagnosis patient will not be eligible, unless this count was during the time of acute infection.
Ambulatory status, and ability and willingness to give informed consent.
Must be over 18 years old and have an estimated life expectancy of more than 12 months.
Hgb greater than or equal to 12 g/dl for men and 11 gm/dl for women.
ANC greater than or equal to 1000/mm(3).
Creatinine greater than or equal to 1.5 mg/dl or creatinine clearance greater than 50 ml/min.
LFT: AST and ALT less than or equal to 3x upper limit of normal IU/ml for enrollment. Alkaline phosphatase less than or equal to 2.5x ULN.
Bilirubin within normal limits, except for known Gilbert's Syndrome or if patient is on protease inhibitor therapy. For patients on protease inhibitor therapy, direct bilirubin less than or equal to 0.3 mg/dl and indirect bilirubin less than or equal to 4.5 mg/dl.
Patients must be willing to comply with a medical regimen of highly active antiretroviral therapy, and must be on a stable antiretroviral regimen for a minimum of 4 weeks prior to the first vaccination.
Patients should not be receiving antiretroviral therapy or should not have received antiretroviral therapy within 6 months.
Patients without actual or suspected allergies to any component of vaccine.
No prior vaccines for HIV.
Patients should not have received treatment with the following meds at study entry or within preceding 3 months - agents with immunomodulating activity, parenteral therapies, HIV drugs, vaccines, interferons, corticosteroids, any growth factors.
No prior Aids defining OI.
No active life threatening infection.
No severe malabsorption.
No evidence of Kaposi Sarcoma or other tumor - likely to require cytotoxic antitumor therapy within 6 months of entering study. Must complete acute therapy for infections at least 14 days prior to entry.
No pregnancy. Female patients of child bearing potential must have a negative pregnancy test prior to vaccine administration. Males and females must agree to use effective birth control methods during the course of vaccination.
No patients in whom there is a medical contraindication or potential problems in complying with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Synthetic HIV Peptide Vaccines (Treatment Protocol)
We are conducting a study to evaluate the safety of two peptide vaccines (given alone or in combination) in patients with early HIV infection. Patients entered onto the study must have >500 CD4 cells/mm(3) and have preserved cardiac, hepatic, renal, and bone marrow function. Patients must be off all anti-retroviral therapy for at least 6 months and may not have received any experimental HIV vaccines. The vaccines being testing in this trial are comprised of short peptide segments of the HIV envelope, including the V3 loop. In animal studies, the peptides were able to induce neutralizing antibodies as well as cytotoxic T responses to HIV. This will be the first trial in which they are given to humans. The study will last for approximately one year, during which time the volunteers will receive 6 peptide vaccines under the skin. For more information, please call Tino Merced-Galindez, R.N. at (301) 496-8959 or Dr. Richard Little at (800) 772-5464.
Read the detailed description
Assessment of toxicity and immunogenicity of two HIV-1 derived peptide vaccines in Montanide ISA-51 (incomplete Freund's adjuvant) given singly and in combination.
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infection
- Being tested
- PCLUS 3-18 MN, PCLUS 6.1 MN
- Keywords
- AIDS, Retrovirus, Therapeutic Vaccine, Vaccine, Helper T Cells
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCLUS 3-18 MNDrug
PCLUS 6.1 MNDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJun 1994
- Study completionJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)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
- Enrolment
- 31 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001386
- Sponsor's protocol ID
- 940159
- Other IDs
- 94-C-0159
- Status last verified
- Jan 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Clerici M, Lucey DR, Zajac RA, Boswell RN, Gebel HM, Takahashi H, Berzofsky JA, Shearer GM. Detection of cytotoxic T lymphocytes specific for synthetic peptides of gp160 in HIV-seropositive individuals. J Immunol. 1991 Apr 1;146(7):2214-9.
PubMed 1826020Ahlers JD, Pendleton CD, Dunlop N, Minassian A, Nara PL, Berzofsky JA. Construction of an HIV-1 peptide vaccine containing a multideterminant helper peptide linked to a V3 loop peptide 18 inducing strong neutralizing antibody responses in mice of multiple MHC haplotypes after two immunizations. J Immunol. 1993 Jun 15;150(12):5647-65.
PubMed 8515081Berzofsky JA, Pendleton CD, Clerici M, Ahlers J, Lucey DR, Putney SD, Shearer GM. Construction of peptides encompassing multideterminant clusters of human immunodeficiency virus envelope to induce in vitro T cell responses in mice and humans of multiple MHC types. J Clin Invest. 1991 Sep;88(3):876-84. doi: 10.1172/JCI115389.
PubMed 1715888
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With Synthetic HIV Envelope Peptides in Patients With Early Human Immunodeficiency Virus Infection
- ClinicalTrials.gov ID
- NCT00001386
- Acronym / sponsor ID
- 940159
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infection
- Keywords
- AIDS, Retrovirus, Therapeutic Vaccine, Vaccine, Helper T Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 1994
- Study completion
- Jan 2002
- First posted
- 4 Nov 1999 (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.
Synthetic HIV Peptide Vaccines (Treatment Protocol)
We are conducting a study to evaluate the safety of two peptide vaccines (given alone or in combination) in patients with early HIV infection. Patients entered onto the study must have >500 CD4 cells/mm(3) and have preserved cardiac, hepatic, renal, and bone marrow function. Patients must be off all anti-retroviral therapy for at least 6 months and may not have received any experimental HIV vaccines. The vaccines being testing in this trial are comprised of short peptide segments of the HIV envelope, including the V3 loop. In animal studies, the peptides were able to induce neutralizing antibodies as well as cytotoxic T responses to HIV. This will be the first trial in which they are given to humans. The study will last for approximately one year, during which time the volunteers will receive 6 peptide vaccines under the skin. For more information, please call Tino Merced-Galindez, R.N. at (301) 496-8959 or Dr. Richard Little at (800) 772-5464.
Detailed description
Assessment of toxicity and immunogenicity of two HIV-1 derived peptide vaccines in Montanide ISA-51 (incomplete Freund's adjuvant) given singly and in combination.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| PCLUS 3-18 MN | Drug | – |
| PCLUS 6.1 MN | Drug | – |
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 4 Mar 2008.
- Background: PubMed 1826020Clerici M, Lucey DR, Zajac RA, Boswell RN, Gebel HM, Takahashi H, Berzofsky JA, Shearer GM. Detection of cytotoxic T lymphocytes specific for synthetic peptides of gp160 in HIV-seropositive individuals. J Immunol. 1991 Apr 1;146(7):2214-9.
- Background: PubMed 8515081Ahlers JD, Pendleton CD, Dunlop N, Minassian A, Nara PL, Berzofsky JA. Construction of an HIV-1 peptide vaccine containing a multideterminant helper peptide linked to a V3 loop peptide 18 inducing strong neutralizing antibody responses in mice of multiple MHC haplotypes after two immunizations. J Immunol. 1993 Jun 15;150(12):5647-65.
- Background: PubMed 1715888Berzofsky JA, Pendleton CD, Clerici M, Ahlers J, Lucey DR, Putney SD, Shearer GM. Construction of peptides encompassing multideterminant clusters of human immunodeficiency virus envelope to induce in vitro T cell responses in mice and humans of multiple MHC types. J Clin Invest. 1991 Sep;88(3):876-84. doi: 10.1172/JCI115389.
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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 PCLUS 3-18 MN and PCLUS 6.1 MN in people with Acquired Immunodeficiency Syndrome and HIV Infection, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 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 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?
On the ClinicalTrials.gov record for NCT00001386, which also lists 3 linked publications.
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 4 Mar 2008.