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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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001386
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: January 2002
  Purpose

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.


Condition Intervention Phase
Acquired Immunodeficiency Syndrome
HIV Infection
Drug: PCLUS 3-18 MN
Drug: PCLUS 6.1 MN
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 31
Study Start Date: June 1994
Estimated Study Completion Date: January 2002
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001386

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001386     History of Changes
Other Study ID Numbers: 940159, 94-C-0159
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
AIDS
Retrovirus
Therapeutic Vaccine
Vaccine
Helper T Cells

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Communicable Diseases
Immunologic Deficiency Syndromes
Infection
Virus Diseases
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014