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A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS Clinical research trials and A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS. A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS clinical trial. Human subjects often receive the most effective healthcare possible for their A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.

Home > "A" Clinical Trials Conditions > A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS

A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS



A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS

For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): American National Red Cross ,
Synopsis: To evaluate whether immune globulin and ganciclovir (DHPG) results in faster initial response as compared to DHPG alone. To evaluate whether immune globulin and DHPG gives longer duration of remission than DHPG alone (i.e. 16 weeks). To evaluate the toxicities of the combination of DHPG and immune globulin as compared to those of DHPG alone. To evaluate if there is a difference between the two groups in regard to survival, immune functions, and CMV viremia and viruria.
Details:
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have the following: - First episode of sight-threatening CMV retinitis. - At least one pending culture for CMV from the blood or urine prior to entry. - Life expectancy > 6 months. - Karnofsky performance = or > 60. - Ability to understand the nature of the study, to comply with study requirements, and to sign informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: - Known selective IGA deficiency or antibodies against IgA. - History of previous episodes of sight-threatening CMV retinitis. Patients with the following are excluded: - Previous episode of sight-threatening CMV retinitis. - Concomitant treatment with other investigational agents except ddI or ddC. - Life expectancy < 6 months. - Continued alcohol or drug abuse. - Known selective IgA deficiency and known to have antibodies against IgA. - Karnofsky performance <60. Other investigational agents except ddI or ddC. ddI ddC
Total Enrollment: 

Location and Contact Information:

Georgetown Univ Med Ctr
Washington D.C.,  District of Columbia,  20007
United States
 


Additional Information:
Study ID Numbers:  079A;  219-90
Study Start Date: 
Record last reviewed: April 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001999

Other Hiv Infections Studies:
1. Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome

2. An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children

3. A Comparison of HIV-Infected Patients with and without Opportunistic (AIDS-Related) Infection

4. A Study of the Safety and Tolerance of Long-Term Therapy with Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons with AIDS

5. A Phase I Study of the Safety of Proleukin (aldesleukin) in Combination with Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis

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A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS
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