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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Collaborator: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000653 |
Purpose
To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT ) (development of toxicity during prolonged AZT therapy), demonstrated disease progression after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months of AZT therapy.
As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Zalcitabine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT |
| Estimated Enrollment: | 140 |
As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.
Patients receive oral ddC for 48 to 177 weeks.
Eligibility| Ages Eligible for Study: | 3 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
AMENDED:
ORIGINAL design:
Patients must have the following:
Allowed at time of study entry:
Prior Medication:
AMENDED:
Allowed:
Exclusion Criteria
Co-existing Condition:
AMENDED:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Contacts and Locations
Hide Study Locations| United States, California | |
| UCSD Med Ctr / Pediatrics / Clinical Sciences | |
| La Jolla, California, United States, 920930672 | |
| Stanford Univ School of Medicine / Pediatrics | |
| Stanford, California, United States, 943054149 | |
| Children's Hosp of Oakland | |
| Oakland, California, United States, 946091809 | |
| Kaiser Permanente / UCLA Med Ctr | |
| Downey, California, United States, 902422814 | |
| UCLA Med Ctr / Pediatric | |
| Los Angeles, California, United States, 900951752 | |
| Cedars Sinai / UCLA Med Ctr | |
| Los Angeles, California, United States, 900481804 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| Northern California Pediatric AIDS Treatment Ctr / UCSF | |
| San Francisco, California, United States, 94143 | |
| United States, Connecticut | |
| Univ of Connecticut Health Ctr / Pediatrics | |
| Farmington, Connecticut, United States, 06032 | |
| United States, District of Columbia | |
| Children's Hosp of Washington DC / Children's Natl Med Ctr | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Univ of Miami (Pediatric) | |
| Miami, Florida, United States, 33161 | |
| United States, Georgia | |
| Emory Univ School of Medicine | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Illinois | |
| Chicago Children's Memorial Hosp | |
| Chicago, Illinois, United States, 606143394 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| Univ of Illinois College of Medicine | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| Univ of Maryland at Baltimore / Univ Med Ctr | |
| Baltimore, Maryland, United States, 21201 | |
| Johns Hopkins Hosp - Pediatric | |
| Baltimore, Maryland, United States, 212874933 | |
| United States, Massachusetts | |
| Children's Hosp of Boston | |
| Boston, Massachusetts, United States, 021155724 | |
| Boston City Hosp / Pediatrics | |
| Boston, Massachusetts, United States, 02118 | |
| Baystate Med Ctr of Springfield | |
| Springfield, Massachusetts, United States, 01199 | |
| Univ of Massachusetts Med Ctr | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, New Jersey | |
| Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | |
| Newark, New Jersey, United States, 071072198 | |
| United States, New York | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| Westchester Hosp | |
| Valhalla, New York, United States, 10595 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| Lincoln Hosp Ctr / Pediatrics | |
| Bronx, New York, United States, 10451 | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 10032 | |
| Mount Sinai Med Ctr / Pediatrics | |
| New York, New York, United States, 10029 | |
| Metropolitan Hosp Ctr | |
| New York, New York, United States, 10029 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10025 | |
| SUNY / Health Sciences Ctr at Brooklyn / Pediatrics | |
| Brooklyn, New York, United States, 11203 | |
| Northshore Hosp / Cornell Univ | |
| Manhasset, New York, United States, 11030 | |
| Schneider Children's Hosp / Long Island Jewish Med Ctr | |
| New Hyde Park, New York, United States, 11042 | |
| Bronx Lebanon Hosp Ctr | |
| Bronx, New York, United States, 10456 | |
| Beth Israel Med Ctr / Pediatrics | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 277103499 | |
| United States, Pennsylvania | |
| Saint Christopher's Hosp for Children | |
| Philadelphia, Pennsylvania, United States, 191341095 | |
| United States, Texas | |
| Texas Children's Hosp / Baylor Univ | |
| Houston, Texas, United States, 77030 | |
| Puerto Rico | |
| UPR Children's Hosp / San Juan City Hosp | |
| San Juan, Puerto Rico, 00936 | |
| Ramon Ruiz Arnau Univ Hosp / Pediatrics | |
| Bayamon, Puerto Rico, 00619 | |
| Study Chair: | Spector SA |
More Information
| Study ID Numbers: | ACTG 138 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000653 History of Changes |
| Health Authority: | Unspecified |
|
Zalcitabine Drug Evaluation Acquired Immunodeficiency Syndrome AIDS-Related Complex |
|
Antimetabolites Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Zalcitabine Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |