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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000865 |
To assess the steady state pharmacokinetic features, tolerance, and safety of orally administered 1592U89, given alone or in combination with other antiretroviral medications, in HIV infected infants and children. To establish doses of 1592U89 appropriate for future pediatric Phase II/III clinical trials.
On the basis of the preclinical and clinical studies, 1592U89 appears to be a promising agent for treatment of HIV infection in children, either as an alternative to currently employed agents, or in combination therapy regimens. A liquid formulation of the drug is available; thus concurrent development of 1592U89 for children and adults is possible.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Abacavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Didanosine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Pharmacokinetics Study |
Official Title: | A Phase I Safety and Pharmacokinetic Study of 1592U89 Alone and In Combination With Other Antiretroviral Agents in Infants and Children With HIV Infection |
Estimated Enrollment: | 32 |
On the basis of the preclinical and clinical studies, 1592U89 appears to be a promising agent for treatment of HIV infection in children, either as an alternative to currently employed agents, or in combination therapy regimens. A liquid formulation of the drug is available; thus concurrent development of 1592U89 for children and adults is possible.
In part 1, patients will receive 1592U89 monotherapy for 12 weeks. Patients will be assigned initially to a low dose of 1592U89 (Dose A). Those patients who tolerate the drug for at least six weeks without a toxicity of grade 3 or above attributable to study drug will have their 1592U89 dose increased (Dose B). If none of those patients experience a life threatening event attributable to study drug, subsequent enrollees will be assigned initially to Dose B. In part 2, each participant will be assigned randomly (1:1:1:1) within their age and Part 1 regimen stratum to one of the four agents: Zidovudine (ZDV), Stavudine (d4T), Didanosine (ddI) or Lamivudine (3TC) in combination with 1592U89.
Ages Eligible for Study: | 3 Months to 13 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication: Required:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with any of the following prior conditions or symptoms are excluded:
- History of intolerance to any of the study drugs.
United States, California | |
UCSD Med Ctr / Pediatrics / Clinical Sciences | |
La Jolla, California, United States, 920930672 | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
United States, Louisiana | |
Tulane Univ / Charity Hosp of New Orleans | |
New Orleans, Louisiana, United States, 701122699 | |
United States, New York | |
Bronx Lebanon Hosp Ctr | |
Bronx, New York, United States, 10457 | |
United States, North Carolina | |
Duke Univ Med Ctr | |
Durham, North Carolina, United States, 277103499 | |
United States, Tennessee | |
Saint Jude Children's Research Hosp of Memphis | |
Memphis, Tennessee, United States, 381052794 | |
United States, Texas | |
Texas Children's Hosp / Baylor Univ | |
Houston, Texas, United States, 77030 |
Study Chair: | Kline M | |
Study Chair: | Van Dyke R | |
Study Chair: | Yogev R | |
Study Chair: | Shenep J |
Study ID Numbers: | ACTG 330 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000865 |
Health Authority: | United States: Federal Government |
Drug Therapy, Combination Reverse Transcriptase Inhibitors Anti-HIV Agents |
Virus Diseases Sexually Transmitted Diseases, Viral Stavudine Didanosine HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Lamivudine Zidovudine Abacavir Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |