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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000805 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cytomegalovirus Infections HIV Infections |
Drug: Ganciclovir |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 32 |
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| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
PER AMENDMENT 10/24/95: Allowed:
Patients must have:
NOTE:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Enrollment of patients on IVIG must be discussed with protocol chair.)
Prior Medication:
Excluded within 30 days prior to study entry:
Contacts and Locations| United States, California | |
| UCSD Med Ctr / Pediatrics / Clinical Sciences | |
| La Jolla, California, United States, 920930672 | |
| Harbor - UCLA Med Ctr / UCLA School of Medicine | |
| Los Angeles, California, United States, 905022004 | |
| Children's Hosp of Los Angeles/UCLA Med Ctr | |
| Los Angeles, California, United States, 900276016 | |
| UCLA Med Ctr / Pediatric | |
| Los Angeles, California, United States, 900951752 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| Children's Hosp of Oakland | |
| Oakland, California, United States, 946091809 | |
| United States, Colorado | |
| Children's Hosp of Denver | |
| Denver, Colorado, United States, 802181088 | |
| United States, Florida | |
| Univ of Miami (Pediatric) | |
| Miami, Florida, United States, 33161 | |
| United States, Illinois | |
| Chicago Children's Memorial Hosp | |
| Chicago, Illinois, United States, 606143394 | |
| United States, Louisiana | |
| Tulane Univ / Charity Hosp of New Orleans | |
| New Orleans, Louisiana, United States, 701122699 | |
| United States, Massachusetts | |
| Children's Hosp of Boston | |
| Boston, Massachusetts, United States, 021155724 | |
| United States, New Jersey | |
| Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | |
| Newark, New Jersey, United States, 071072198 | |
| Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 10032 | |
| Incarnation Children's Ctr / Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 10032 | |
| United States, Pennsylvania | |
| Saint Christopher's Hosp for Children | |
| Philadelphia, Pennsylvania, United States, 191341095 | |
| United States, Texas | |
| Univ of Texas Galveston | |
| Galveston, Texas, United States, 775550435 | |
| United States, Washington | |
| Children's Hospital & Medical Center / Seattle ACTU | |
| Seattle, Washington, United States, 981050371 | |
| Study Chair: | Frenkel L | |
| Study Chair: | Dankner W |
More Information
| ClinicalTrials.gov Identifier: | NCT00000805 History of Changes |
| Other Study ID Numbers: | ACTG 226 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 11, 2008 |
| Health Authority: | United States: Federal Government |
|
Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome |
|
HIV Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Herpesviridae Infections DNA Virus Infections Ganciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |