|
A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients. Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients. conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients. Clinical research trials and A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients. medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients.. A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients. Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients. clinical trial. Participants oftentimes recieve the finest healthcare available for their A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients. condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients.  A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients.
A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients.
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: To study the safety and toxicity of intranasal peptide T (D-Ala-1-peptide-T-amide) in humans, and to find out how quickly and how much of a given dose enters the bloodstream and how quickly it leaves the bloodstream. To obtain information on the ability of intranasal peptide T to prevent, halt, and/or reverse the effects of AIDS on the central nervous system. Studies have shown that AIDS is caused by a retrovirus. This virus works by inactivating or destroying human CD4 cells (which are part of the human immune system). This in turn leads to the observed immunologic defects and related illnesses, including HIV encephalopathy (disease of the brain). One method of preventing AIDS is to prevent HIV from entering the cell. HIV binds to the receptor CD4 site. Peptide T also binds to this site, and thus by competing for that site, can block the binding of the virus to its receptor. Preliminary animal and human studies indicate that peptide T is safe at the doses selected for this trial. Thirty patients with AIDS or AIDS related complex (ARC) are entered into the study to receive an increasing schedule of three dosage levels of intranasal peptide T for 12 - 16 weeks followed by a 1-month off-drug follow-up period and a subsequent 1-month return to the drug. All patients receive an initial intravenous test dose of peptide T. The test dose is administered over 1 hour, followed by an observation period of 8 hours in the outpatient clinic.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients must have: HIV infection. Ability to give informed consent. Ability to participate in an outpatient study. - Allowed: Short course antimicrobials. - Not breast-feeding - Abstinence or agree to use barrier methods of birth control / contraception during the study - Not pregnant - Negative pregnancy test - CD4 100 to 500 cells/mm3 (100 - 200 - 300 - 400 - 500). - Creatinine > 1.6 mg/dl - Hemoglobin >= 12 g/dl - Platelet Count >= 100000 /mm3 Exclusion Criteria: - Excluded: Asymptomatic HIV seropositive or lymphadenopathy syndrome diagnoses only (CDC criteria). - Patients with the following conditions are excluded: Evidence of life-threatening opportunistic infection at time of entry into trial. Clinical evidence of active central nervous system disease secondary to immune dysregulation associated with HIV infection. Previous history of major psychiatric illness prior to 1977 or the time of initial exposure to HIV, if that is known. Evidence of clinically significant major psychiatric disturbance other than depression. - Excluded within 4 weeks of study entry: Suramin. Antiretroviral agents. Anticancer treatments. Psychoactive agents. - Excluded: Antivirals or immunomodulators. - Excluded within 4 weeks of study entry: Radiation. - Evidence of active substance abuse during 30 days prior to entry into trial. All behavior that can put patient at risk for reinfection with HIV: sexual contact with others known to have HIV infection, unsafe sexual practices, or sharing of needles or other intravenous equipment. - Breast-feeding - Positive pregnancy test - Pregnant - No abstinence or no agreement to use barrier methods of birth control / contraception during the study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BridgeTP, Study Chair,
Fenway Clinic
Boston, Massachusetts,
United States
Additional Information:
Study ID Numbers: 89 MH-SF;
Study Start Date:
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000391
Other Hiv Infections Studies:
1. A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease
2. Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
3. A Phase I /II Study of the Protease Inhibitor Indinavir (MK-0639) in Children with HIV Infection
4. The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU
5. Using the Drug Thalidomide to Stimulate T Cells in HIV Positive Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients.
|
|
|
|
|
|
|
|
