|
A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir Clinical research trials and A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir. A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain 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 Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir  A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Hoffmann-La Roche
Synopsis: To determine the pharmacokinetics (blood levels) of three dose treatment plans of oral ganciclovir during a 28-day dosing period. Other purposes of the study are to determine in a population of HIV seropositive persons with cytomegalovirus (CMV) viremia, the safety, tolerance, and patient acceptability of oral ganciclovir given for 28 days, to collect preliminary laboratory evidence for antiviral activity and effectiveness of three dose regimens of oral ganciclovir based on blood and urine cultures of CMV, and to relate antiviral activity to dosage and to serum ganciclovir levels. CMV retinitis is an important sight-threatening opportunistic infection which affects about 10 to 15 percent of people with AIDS. A previous study has shown that treatment with ganciclovir resulted in a significant delay in time to first retinitis progression compared to untreated controls. More studies are warranted to evaluate effects at different doses.
Details: CMV retinitis is an important sight-threatening opportunistic infection which affects about 10 to 15 percent of people with AIDS. A previous study has shown that treatment with ganciclovir resulted in a significant delay in time to first retinitis progression compared to untreated controls. More studies are warranted to evaluate effects at different doses. In group A, 36 HIV seropositive patients with CMV viruria receive a single dose of intravenous ganciclovir followed by one of three oral dose regimens for 28 days. Twelve individuals are treated at each dose level. In group B, 12 patients with AIDS and CMV retinitis receive oral ganciclovir therapy. These 12 patients must have received an induction course of intravenous ganciclovir for 4 weeks prior to study entry and must have stable CMV retinitis. Measurements for both groups include pharmacokinetics, safety, and tolerance (history, physical examination, hematology, and serum chemistry), and CMV blood and urine cultures. In addition, there are weekly ophthalmologic evaluations for individuals in the group B study.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 13 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Topical acyclovir. There are two groups of patients. Group A must have: - Confirmation of HIV infection by HIV antibody testing, p24 antigen, or culture of HIV. - A positive urine culture for cytomegalovirus (CMV) within 4 weeks of study entry. - Not received prior ganciclovir therapy. Group B must have: - A diagnosis of AIDS by CDC criteria. - CMV retinitis diagnosed on funduscopic evaluation by an ophthalmologist. - Completed 4 weeks of intravenous ganciclovir with an improvement or stabilization of retinitis. The course of therapy should include a minimum of 24 days total of intravenous ganciclovir. - Patients in both groups must understand the nature of the study, agree to the tests required in the protocol, and must understand and sign an informed consent form approved by the appropriate Institutional Review Board (IRB) and by Syntex. Required: Group B: - 4 weeks of intravenous ganciclovir which should include a minimum of 24 days total of intravenous ganciclovir. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Macular involvement due to cytomegalovirus (CMV) retinitis in both eyes. - Active CMV retinitis in which there is progression. - Presence of diarrhea or other clinically significant or uncontrolled gastrointestinal disease including persistent nausea and/or abdominal pain. Diarrhea is defined as > 3 unformed stools/day. - Dementia or decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to follow the protocol, to take assigned dose regimen reliably, and to keep a daily record on a calendar. - Significant CMV disease of other organs, including CMV gastroenteritis or CMV pneumonia. Concurrent Medication: Excluded: - Any investigational drug. - Acyclovir not specifically allowed. - Any other nucleoside analog. - Zidovudine (AZT). - Probenecid. - Aspirin. Patients with the following are excluded: - Macular involvement due to cytomegalovirus (CMV) retinitis in both eyes. - Active CMV retinitis in which there is progression. - CMV end organ disease. - Presence of diarrhea or other clinically significant or uncontrolled gastrointestinal disease including persistent nausea and/or abdominal pain. Diarrhea is defined as > 3 unformed stools/day. - Dementia or decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to follow the protocol, to take assigned dose regimen reliably, and to keep a daily record on a calendar. - Significant CMV disease of other organs, including CMV gastroenteritis or CMV pneumonia. Prior Medication: Excluded within 4 days of study entry: - Antimetabolite. - Interferon. - Other nucleoside analog including zidovudine (AZT). Excluded for Group A: - Ganciclovir or other anti-cytomegalovirus therapy.
Total Enrollment: 48
Location and Contact Information:
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Davies Med Ctr
San Francisco, California, 94114
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Mount Zion Med Ctr
San Francisco, California, 94115
United States
Additional Information:
Study ID Numbers: ACTG 127; ICM 1505,FDA 37A,RS-21592
Study Start Date:
Record last reviewed: March 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000668
Other Cytomegalovirus Retinitis Studies:
1. A Study of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
2. A Study of Cidofovir in HIV-Infected Children with Cytomegalovirus (CMV) Disease
3. A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
4. Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT)
5. A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
Related Studies:
Other Cytomegalovirus Retinitis Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
|
|
|
|
|
|
|
|
