|
A Study of GENEVAX-HIV, a Possible Vaccine Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Study of GENEVAX-HIV, a Possible Vaccine conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of GENEVAX-HIV, a Possible Vaccine Clinical research trials and A Study of GENEVAX-HIV, a Possible Vaccine medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as A Study of GENEVAX-HIV, a Possible Vaccine. A Study of GENEVAX-HIV, a Possible Vaccine Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Study of GENEVAX-HIV, a Possible Vaccine clinical trial. Participants frequently get the best healthcare available for their A Study of GENEVAX-HIV, a Possible Vaccine condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Study of GENEVAX-HIV, a Possible Vaccine  A Study of GENEVAX-HIV, a Possible Vaccine
A Study of GENEVAX-HIV, a Possible Vaccine
For Condition: HIV Infections,HIV Seronegativity
Status: Completed
Sponsor(s): Wyeth-Lederle Vaccines ,
Synopsis: The purpose of this study is to see if it is safe to give GENEVAX-HIV, a potential HIV vaccine, to HIV-negative volunteers. The study also compares the effects of GENEVAX-HIV injected into the muscle to the effects of the drug when injected into the skin.
Details: Volunteers receive either intradermal or intramuscular injections of GENEVAX-HIV; humoral and cellular responses are assessed accordingly.
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Good health. - Ability to understand the basis of HIV transmission and other common sexual and blood-borne infections. - The following parameters within normal range: -Hematopoietic: - total white blood cell, lymphocyte, granulocyte, and platelet count, hemoglobin and hematocrit. -Renal: - BUN and creatinine, urinalysis. -Hepatic: - total serum bilirubin. -Endocrine/Metabolic: - Serum calcium, serum glucose, total serum CPK. -Immunologic: - total serum immunoglobulin and absolute CD4 count. -Hepatitis B and Hepatitis C negative. -Urinalysis: - Normal screen with dipstick for esterase and nitrite. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - HIV-seropositive status. - Any positive result for anti-DNA antibodies considered of potential clinical significance as measured by anti-DNA antibody and/or anti-nuclear antibody (ANA) assays. - Any condition which, in the opinion of the principal investigator, might interfere with completion of the study or evaluation of the results. - Known hypersensitivity to bupivacaine or any amide-type local anesthetic (such as lidocaine, dibucaine, mepivacaine, and prilocaine) or a history of anaphylaxis or other serious adverse reactions to vaccines. Concurrent Medication: Excluded: Any medication which may affect immune function with the exception of low doses of nonprescription-strength NSAIDS, aspirin, or acetaminophen for acute conditions such as headache or trauma. Patients with the following prior conditions are excluded: - HIV-seropositive. - Known or suspected history of impairment or abnormality in immune functioning. - Exposure to potentially-infective HIV fluids within the prior 6 months or tested positive for HIV at any time. - History of any prior disease or therapy which would affect immune function including: -Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma in situ of the cervix. -Immunodeficiency or autoimmune disease. -Acute infection or a recent (within 6 months) history of chronic infection. - History of serious allergic reaction to any substance requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension). Prior Medication: Excluded: Cytotoxic chemotherapy that may affect immune function. Prior Treatment: Excluded: - Previous immunization with any experimental vaccines directed against HIV or receipt of any experimental agent within 30 days prior to enrollment. - Receipt of any blood products or immunoglobulin within 6 months prior to enrollment. - Exposure to live attenuated vaccines within 60 days of study. - Radiotherapy that may affect immune function. Risk Behavior: Excluded: - Active drug or alcohol abuse or uncontrolled (unstable) psychiatric disorders which, in the opinion of the investigator, would interfere with study participation. - Higher- or intermediate-risk sexual behavior (AVEG criteria)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MerlinRobb, Study Chair,
Walter Reed Army Institute of Research
Washington D.C., District of Columbia, 20307
United States
Additional Information:
Study ID Numbers: 005; 400-003-05
Study Start Date:
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002232
Other Hiv Seronegativity Studies:
1. A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea
2. Comparison of New Anti-HIV Drug Combinations in HIV-Infected Children Who Have Taken Anti-HIV Drugs
3. Phase III Open Label Atazanavir (BMS-232632) in Combination with Ritonavir or Saquinavir, and Lopinavir/Ritonavir, each with Tenofovir and a Nucleoside in Subjects with HIV
4. Fuzeon (Enfuvirtide) Early Access Program for Patients with HIV-1 Infection
5. Reducing the Transmission of HIV in China
Related Studies:
Other HIV Seronegativity Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
A Study of GENEVAX-HIV, a Possible Vaccine
|
|
|
|
|
|
|
|
