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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. The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs
2. A Phase I Safety and Immunogenicity Study of HIV p17/p24:Ty-VLP in HIV-1 Seronegative Subjects
3. The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs
4. Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults
5. A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients with Acquired Immunodeficiency Related Diarrhea who were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.
Related Studies:
Other HIV Infections Clinical Trials
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Other Research Triangle Park Clinical Trials
A Prospective Double-Blind Study of Retrovir in Early HIV Infection
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