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A Prospective Double-Blind Study of Retrovir in Early HIV Infection Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on A Prospective Double-Blind Study of Retrovir in Early HIV Infection conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Prospective Double-Blind Study of Retrovir in Early HIV Infection Clinical research trials and A Prospective Double-Blind Study of Retrovir in Early HIV Infection healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including A Prospective Double-Blind Study of Retrovir in Early HIV Infection. A Prospective Double-Blind Study of Retrovir in Early HIV Infection Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a A Prospective Double-Blind Study of Retrovir in Early HIV Infection clinical trial. Participants typically obtain the most effective healthcare available for their A Prospective Double-Blind Study of Retrovir in Early HIV Infection condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Prospective Double-Blind Study of Retrovir in Early HIV Infection  A Prospective Double-Blind Study of Retrovir in Early HIV Infection
A Prospective Double-Blind Study of Retrovir in Early HIV Infection
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) to adult patients with early manifestations of HIV disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients. (12/01/89) Information supplied by drug company update. Study discontinued due to positive data from ACTG 016.
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Treatment: Allowed: - Electron beam therapy to an area of less than 100 cm2. Patient must have signs and symptoms of HIV infection confined to those of stages WRII-V or CDC groups III IV-A, IV-C-2 (except recurrent Salmonella bacteremia, nocardiosis, or disseminated/extrapulmonary Mycobacterium tuberculosis), and IV-E (except diffuse interstitial lymphoid pneumonitis). - Patient must be able to give informed consent. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse. - Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria. - Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS: - extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis. - Evidence of compromised bone marrow function defined by specified lab values. - Evidence of HIV neurologic disease. - Evidence of HIV-associated "wasting syndrome". - Hypersensitivity to zidovudine (AZT). Concurrent Medication: Excluded: - Cytotoxic chemotherapeutic agents. - Steroids. - Interferon or immunomodulating agents. - Any antiretroviral drug including, but not limited to zidovudine (AZT), ribavirin, HPA23, AL 721, or phosphonoformate. Patients with the following are excluded: - Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse. Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria. Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS: - extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis. - Evidence of compromised bone marrow function defined by specified lab values. Evidence of HIV neurologic disease. - Evidence of HIV-associated wasting syndrome. - Hypersensitivity to retrovir. Prior Medication: Excluded within 4 weeks of study entry: - Interferon. - Immunomodulating agents. - Myelosuppressive drugs. - Nephrotoxic agents. - Other experimental chemotherapy. Prior Treatment: Excluded: - Treatment with radiation therapy (with the exception of electron beam therapy to an area of less than 100 cm2). Chronic alcohol or drug abuse.
Total Enrollment:
Location and Contact Information:
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709
United States
Additional Information:
Study ID Numbers: 014E; 15
Study Start Date:
Record last reviewed: December 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002045
Other Hiv Infections Studies:
1. Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents
2. A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
3. A Study of DPC 817 in HIV-Infected Males
4. A Phase I/II Study of Recombinant Interleukin-4 in AIDS and Kaposi's Sarcoma
5. A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir)
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Research Triangle Park Clinical Trials
A Prospective Double-Blind Study of Retrovir in Early HIV Infection
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