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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 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about 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 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like 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. 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 Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects typically obtain the finest healthcare available for their 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 condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > 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  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
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
For Condition: Acquired Immunodeficiency Syndrome,HIV Infection
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 31
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 940159; 94-C-0159
Study Start Date: June 7, 1994
Record last reviewed: January 10, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001386
Other Acquired Immunodeficiency Syndrome Studies:
1. Home Treatment of HIV-Infected Patients with Interleukin-2 with or without a Tumor Necrosis Factor Antagonist
2. Psychosocial Correlates and Coping Strategies Associated with Long-Term Survival of HIV-Infected Children
3. Immune restoration by lipoic acid in AIDS
4. Pulmonary Complications of HIV Infection Study (PACS)
5. Ganciclovir Implant Study for Cytomegalovirus Retinitis
Related Studies:
Other Acquired Immunodeficiency Syndrome Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
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
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