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Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals 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 Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals Clinical research trials and Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals 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 Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals. Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals 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 Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals clinical trial. Participants oftentimes recieve the finest healthcare available for their Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals 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.
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Home > "E" Clinical Trials Conditions > Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals  Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To ascertain whether the origin of plasma HIV-1-RNA following T cell activation represents the activation of latently infected cells or an increase in cells permissive for replacing viral mutants. The mechanism by which immune stimulation increases circulating levels of HIV-1 is not known. In particular, it is uncertain whether the transient increase in plasma HIV-1 RNA is due to enhanced replication of an actively replicating pool of HIV-1, or is due instead to activation of proviral sequences in previously resting CD4+ cells. One approach to discriminate these alternatives is a "molecular pulse-chase" experiment. In this approach, drug resistant mutants would be selected by administration of Lamivudine (3TC).
Details: The mechanism by which immune stimulation increases circulating levels of HIV-1 is not known. In particular, it is uncertain whether the transient increase in plasma HIV-1 RNA is due to enhanced replication of an actively replicating pool of HIV-1, or is due instead to activation of proviral sequences in previously resting CD4+ cells. One approach to discriminate these alternatives is a "molecular pulse-chase" experiment. In this approach, drug resistant mutants would be selected by administration of Lamivudine (3TC). Twenty subjects without prior 3TC experience will be treated with 3TC for 2 weeks. On day 14, half of the subjects will receive immunization with both the influenza and pneumococcal vaccine. 3TC will be discontinued at this time. Patients will be followed for 4 weeks after the immunization.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antiretroviral therapy, provided the patient has been on the same dose and drugs for 60 days prior to study entry. Patients must have: - Documented HIV infection. - CD4 lymphocyte count of > 300 cells/mm3. - One plasma HIV-1 RNA level between >= 20,000 and < 120,000 copies/ml. Prior Medication: Allowed: - Stable antiretroviral therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Presence of an AIDS defining opportunistic infection, including Kaposi's sarcoma. - Allergy to influenza or pneumococcal vaccine or their components; to egg or egg products. - Unexplained temperature >= 38.5 degrees C for 7 consecutive days within the 30 days prior to study entry. - Concurrent participation in other experimental therapies. Concurrent Medication: Excluded: - Systemic chemotherapy. - Steroids. - Corticosteroids. - Vaccinations. - Any new antiretroviral agents that the patient was not taking at the time of study entry and not prescribed by the study. - Colony stimulating factors including G-CSF or rEPO. - Immune modulators/immune based therapies. Concurrent Treatment: Excluded: - Radiation therapy. - Transfusion dependent patients. Patients with any of the following prior conditions are excluded: - History of an AIDS defining opportunistic infection, including Kaposi's sarcoma (except limited cutaneous diseases [< 5 lesions]). - History of acute or chronic pancreatitis. Prior Medication: Excluded: - Prior treatment with 3TC. Excluded within 30 days of study entry: - Treatment with immune modulators. - Acute or chronic therapy for recognized infections (eg, influenza, HSV, VZV). Excluded within 1 year of study entry: Treatment with an influenza and/or pneumonia vaccine [AS PER AMENDMENT 1/23/97: - influenza vaccine only]. [AS PER AMENDMENT 1/23/97: - Excluded within 3 years of study entry: - Pneumonia vaccine.]
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
KuritzkesD, Study Chair,
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Additional Information:
Study ID Numbers: ACTG 340;
Study Start Date:
Record last reviewed: April 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001080
Other Hiv Infections Studies:
1. A Phase I Trial of Peptide T: Efficacy for the Neuropsychiatric Complications of Acquired Immunodeficiency Syndrome (AIDS).
2. Study of a New Protease Inhibitor, BMS-232632, in Combination with Other Anti-HIV Drugs
3. Safety/Immunogenicity of Immunizations of ALVAC-DC-SC vs ALVAC-SC
4. Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People
5. A Comparison of Two Dose Levels of Indinavir Combined with Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
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Other Denver Clinical Trials
Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
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