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Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One treatment arm receives placebo) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One treatment arm receives placebo) conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One treatment arm receives placebo) Clinical research trials and Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One treatment arm receives placebo) health trials occur in hundreds of cities 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One treatment arm receives placebo). Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One treatment arm receives placebo) Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One treatment arm receives placebo) clinical trial. Participants oftentimes recieve the most expert healthcare available for their Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One treatment arm receives placebo) condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One treatment arm receives placebo)  Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One treatment arm receives placebo)
Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One treatment arm receives placebo)
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Glaxo Wellcome
Synopsis: To evaluate the safety and efficacy of early treatment with zidovudine for preventing a decline in CD4+ lymphocyte counts in patients with primary HIV infection. To determine the natural history of virologic and immunologic changes in primary HIV infection. Previous studies indicate that intervention with zidovudine during primary HIV infection could reduce the initial viral burden and subsequent decline in immune functions, and could prolong not only the time to development of AIDS but also the time to initiation of chronic antiretroviral therapy.
Details: Previous studies indicate that intervention with zidovudine during primary HIV infection could reduce the initial viral burden and subsequent decline in immune functions, and could prolong not only the time to development of AIDS but also the time to initiation of chronic antiretroviral therapy. Patients are randomized to receive either zidovudine or placebo daily for 24 weeks. Patients are followed until development of an AIDS-related opportunistic infection or malignancy. After week 24, patients meeting standard prescribing criteria may start FDA-approved anti-HIV therapies. After study week 48, patients may co-enroll on another clinical trial to receive experimental therapy.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Medications for nausea, vomiting, analgesia, or anxiety. Patients must have: - Asymptomatic or symptomatic primary HIV infection, plus one of the following two criteria: a) p24 antigenemia documented within 1 month prior to study entry and either HIV enzyme immunoassay (IA) negative or HIV IA positive with Western blot negative/indeterminate, within 1 month prior to study entry. b) Documented seroconversion within 1 month prior to study entry and Western blot negative/indeterminate. - Consent of parent or guardian if less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following condition are excluded: - poor venous access. Concurrent Medication: Excluded: - Chronic steroid use. - Immunomodulators. - Myelosuppressive agents. - Other antiretroviral agents or experimental therapies (NOTE: FDA-approved therapies permitted in patients who qualify after week 24; experimental therapies permitted after study week 48).
Total Enrollment: 80
Location and Contact Information:
Overall Study Official:
MNiu, Study Chair,
Univ of Illinois
Chicago, Illinois, 60612
United States
Cedars Sinai Med Ctr
Los Angeles, California, 90048
United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 212872080
United States
Broward Gen Med Ctr
Ft. Lauderdale, Florida, 33316
United States
Palo Alto Veterans Administration Med Ctr
Palo Alto, California, 94304
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Houston Clinical Research Network
Houston, Texas, 77006
United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Additional Information:
Study ID Numbers: DATRI 002;
Study Start Date:
Record last reviewed: December 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000765
Other Hiv Infections Studies:
1. Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2
2. A Phase I Study of Subcutaneously Administered Proleukin (aldesleukin) in HIV-Infected Patients
3. Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients with Drug-resistant HIV
4. Quality of Life in Children with HIV Infection
5. Safety and Effectiveness of Giving L-743,872 to Patients with Thrush That Has Not Been Cured With Fluconazole
Related Studies:
Other HIV Infections Clinical Trials
Other Rhode Island Clinical Trials
Other Providence Clinical Trials
Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One treatment arm receives placebo)
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