|
A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease Clinical research trials and A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease. A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease clinical trial. Subjects typically recieve the finest healthcare available for their A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
For Condition: Cytomegalovirus Infections,HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: PRIMARY: To determine the pharmacokinetics, MTD, and long-term safety and tolerance of oral ganciclovir in HIV-infected infants, children, and adolescents. SECONDARY: To evaluate the effect of oral ganciclovir on the virologic parameters of CMV. Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS patients is now standard therapy, but daily IV therapy can be complicated by catheter infections and thrombosis. An oral regimen of ganciclovir has been administered safely in adult AIDS patients and may be of significant benefit to children and infants as well.
Details: Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS patients is now standard therapy, but daily IV therapy can be complicated by catheter infections and thrombosis. An oral regimen of ganciclovir has been administered safely in adult AIDS patients and may be of significant benefit to children and infants as well. Patients are assigned to 1 of 5 (PER AMENDMENT 10/24/95, was 4) oral (syrup or capsules) dose levels following a single intravenous dose of ganciclovir. Treatment continues for 72 (PER AMENDMENT 10/24/95, was 24 weeks) weeks after the last patient has been enrolled.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: /20 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: PER AMENDMENT 10/24/95: Allowed: - All antiretroviral agents and other medications except those listed under Exclusion - Concurrent Medications. - Didanosine. However, patients receiving both drugs (didanosine and ganciclovir) should be monitored for toxicity. - Amphotericin B is allowed but requires additional monitoring. Patients must have: - HIV infection. - CMV infection. - CD4 count < 150 cells/mm3 or < 15 percent AND/OR quiescent CMV disease. - NO loss of sight from CMV retinitis. - NO acute opportunistic infection. - Life expectancy at least to study completion. - Consent of parent or guardian. NOTE: - Infants < 6 months of age at enrollment must have been >= 36 weeks gestational age at birth. NOTE: - Patients may co-enroll in other ACTG protocols that do not involve the administration of disallowed medications. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Loss of sight in one eye for any reason, with evidence of CMV retinitis in the other eye. - Acute or chronic diarrhea that would affect absorption. - Clinical or laboratory toxicities of grade 3 or worse. Concurrent Medication: Excluded: - Foscarnet. - Acyclovir. - Interferon. - Myelotoxic agents for malignancy or other condition. - Other agents with anti-CMV activity. (NOTE: Enrollment of patients on IVIG must be discussed with protocol chair.) - Imipenem/cilastatin sodium. Prior Medication: Excluded within 30 days prior to study entry: - G-CSF or GM-CSF.
Total Enrollment: 32
Location and Contact Information:
Overall Study Official:
FrenkelL, Study Chair,
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Additional Information:
Study ID Numbers: ACTG 226;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000805
Other Cytomegalovirus Infections Studies:
1. A Pilot/Dose-Finding Study of the Toxicity, Anti-Kaposi's Sarcoma (KS) Activity, and Immunologic Activity of Interleukin-12 Administered to Patients with AIDS-Associated KS
2. Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3
3. Safety and Effectiveness of Combining Hydroxyurea (HU) with Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults
4. A Phase I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease.
5. Effects of Changing HIV Therapy at Lower Versus Higher Viral Loads
Related Studies:
Other Cytomegalovirus Infections Clinical Trials
Other California Clinical Trials
Other Oakland Clinical Trials
A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
|
|
|
|
|
|
|
|