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CLINICAL TRIALS PROFILE FOR RETROVIR

Clinical Trials for Retrovir

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00000662	A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease	Completed	Glaxo Wellcome	N/A	To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who are HIV-infected and either symptomatic or have a CD4 cell count < 400 cells/mm3 and to monitor adverse effects of AZT. Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.
NCT00000662	A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who are HIV-infected and either symptomatic or have a CD4 cell count < 400 cells/mm3 and to monitor adverse effects of AZT. Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.
NCT00000716	A Multicenter Trial To Evaluate Oral Retrovir in the Treatment of Children With Symptomatic HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	To evaluate the safety and tolerance of oral zidovudine (AZT) when given over a period of 24 weeks to children between 3 months and 12 years of age. The effectiveness of AZT in treating HIV infection in infants and children will also be evaluated. HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in altering the course of the disease and decreasing mortality in these children. AZT has been shown to be effective in certain adult patients with symptomatic HIV infection. It is therefore likely that infected children may also benefit from this treatment.
NCT00002020	Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients With AIDS or Advanced ARC	Completed	Glaxo Wellcome	N/A	To evaluate the safety and tolerance, in patients with severe clinical manifestations of HIV infection, of zidovudine (AZT) administered daily for 48 weeks as a low dose every 4 hours or a higher dose every 12 hours.
NCT00002028	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)	Completed	Bristol-Myers Squibb	N/A	The objective of this treatment IND protocol is to make didanosine (ddI) available to patients with HIV infection (suffering from AIDS related complex (ARC) or AIDS) who have developed documented intolerance to zidovudine (AZT) and cannot enter a Phase II ddI program due to protocol exclusion or geographic location.
NCT00002044	A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases	Completed	Glaxo Wellcome	N/A	The purpose of this pilot study is to evaluate the efficacy of Retrovir (AZT) in the treatment of AIDS-related dementia and various neuromuscular complications. HIV is both a lymphotropic and neurotropic virus which can affect both the central and peripheral nervous systems (CNS, PNS). There is evidence that the CNS and PNS may harbor the virus in a latent state, with the potential for continuous reinfection of other body systems. Therefore, effective therapeutic efforts against HIV infection should provide effective antiviral activity within the nervous system.
Trial ID	Title	Status	Sponsor	Phase	Summary