|
A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy Clinical research trials and A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy. A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy clinical trial. Human subjects often obtain the finest healthcare possible for their A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy  A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: AMENDED: 04-12-91 Population of patients changed FROM those who are intolerant of systemic therapy with NON-sight-threatening CMV retinitis TO those AIDS patients intolerant of systemic therapy with CMV retinitis. AMENDED: 8/8/90. Changes made in neutrophils count from < 500 to < 750 cells/mm3. Nonrandomized eyes will not be used for the primary efficacy evaluation. ORIGINAL DESIGN: To determine the effectiveness and safety of ganciclovir (DHPG) therapy in AIDS patients suffering from active cytomegalovirus (CMV) infection of the retina of the eye (retinitis) when the drug is administered directly into the fluid-filled vitreous cavity of the eye by injection. CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS patients, and left untreated can lead to severe visual loss and blindness. While systemic administration of DHPG has been shown to be an effective treatment for CMV retinitis, the chronic administration required may be complicated by decreased blood cell counts (granulocytopenia) which may require discontinuation of treatment. While withholding treatment may allow recovery from the granulocytopenia, interruption of therapy may result in reactivation of the retinitis. Injection of DHPG into the vitreous cavity of the eye may be of benefit to severely neutropenic patients with CMV retinitis.
Details: CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS patients, and left untreated can lead to severe visual loss and blindness. While systemic administration of DHPG has been shown to be an effective treatment for CMV retinitis, the chronic administration required may be complicated by decreased blood cell counts (granulocytopenia) which may require discontinuation of treatment. While withholding treatment may allow recovery from the granulocytopenia, interruption of therapy may result in reactivation of the retinitis. Injection of DHPG into the vitreous cavity of the eye may be of benefit to severely neutropenic patients with CMV retinitis. Patients must have active CMV retinitis in one or both eyes, despite prior systemic therapy. Following medical evaluation, the decision is made whether to treat the eye(s) immediately or to watch the eye(s) carefully for advancement of the retinitis. Eyes with sight-threatening lesions or eyes without functional vision are treated immediately and eyes without sight-threatening lesions are randomly chosen for either immediate or deferred therapy. DHPG is given by injection with a very fine needle twice a week for the first 3 weeks and once a week for the remaining 24 weeks.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 13 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Zidovudine (AZT). - AMENDED: 8/8/90 Other available antiretroviral therapy. - Pneumocystis carinii pneumonia (PCP) prophylaxis, either systemic or local (aerosolized). - Chemotherapy for Kaposi's sarcoma. - Systemic therapy for intercurrent opportunistic infections. - Acyclovir or other treatment of Herpes simplex virus (HSV) or Varicella zoster virus (VZV) infections. - Systemic therapy deemed necessary for appropriate medical management. Patients must have AIDS and cytomegalovirus (CMV) retinitis in at least one eye, diagnosed by an ophthalmologist and verified by fundoscopy and fundus photography. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Contraindication to intravitreal injection, including obvious external infection and vitreous hemorrhage. - Medical opacities of cornea, lens, and/or vitreous which precludes fundus photography. Concurrent Medication: Excluded: - Prophylactic acyclovir at time of study entry. - Other anticytomegalovirus (CMV) therapy, particularly systemic ganciclovir, foscarnet, or CMV hyperimmune globulin. - Topical ophthalmic medications should be avoided. - Cytomegalovirus (CMV) therapies and chronic acyclovir, including necessary therapies for an intercurrent opportunistic infection. Patients with the following are excluded: - Contraindication to intravitreal injection, including obvious external infection and vitreous hemorrhage. - Medical opacities of cornea, lens, and/or vitreous which precludes fundus photography.
Total Enrollment: 38
Location and Contact Information:
Overall Study Official:
PolskyB, Study Chair,
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Additional Information:
Study ID Numbers: ACTG 085;
Study Start Date:
Record last reviewed: October 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000673
Other Hiv Infections Studies:
1. Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily
2. Effect of Interleukin-2 on HIV Treatment Interruption
3. A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated with Anti-HIV Drugs
4. A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
5. Safety and Efficacy of Intravenous Magnesium Sulfate in Modulating Changes in Symptoms and Divalent Cation Levels Associated With Foscavir Therapy: A Phase IV Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Pilot Study
Related Studies:
Other HIV Infections Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
|
|
|
|
|
|
|
|
