The Safety and Effects of 1592U89 Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Infants and Children
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| ClinicalTrials.gov Identifier: NCT00000865 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : February 16, 2012
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Abacavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Didanosine | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 32 participants |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Completion Date : | April 1998 |
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| Ages Eligible for Study: | 3 Months to 13 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- IVIG.
- Erythropoietin, granulocyte colony stimulating factor and granulocyte macrophage colony stimulating factor (for management of hematologic toxicity).
Patients must have:
- Documented HIV-1 infection.
- Laboratory evidence of immunosuppression or symptomatic HIV disease.
- Parent or legal guardian able and willing to provide signed informed consent.
Prior Medication: Required:
- HIV infected infants and children will be eligible for the trial if they have received greater than 56 days of previous antiretroviral therapy.
NOTE:
- Those children who participated in the single dose phase I study of 1592U89 and satisfy all other criteria for inclusion may have received <= 56 days of previous antiretroviral therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Grade 3 or greater abnormalities in any toxicity monitoring laboratory tests at baseline.
- Presence of an acute opportunistic infection requiring therapy at the time of enrollment.
- Intractable or chronic diarrhea or vomiting.
Concurrent Medication:
Excluded:
- Chemotherapy for active malignancy.
- Concurrent use of antiretroviral agents other than those provided by the study, biologic response modifiers, human growth hormone, systemic corticosteroids (>= 14 days duration), probenecid, I.V. pentamidine, immunomodulators (other than intravenous immunoglobulin), or other investigational drugs.
Patients with any of the following prior conditions or symptoms are excluded:
- History of intolerance to any of the study drugs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000865
| United States, California | |
| Usc La Nichd Crs | |
| Los Angeles, California, United States, 90033 | |
| UCSD Maternal, Child, and Adolescent HIV CRS | |
| San Diego, California, United States, 920930672 | |
| United States, Louisiana | |
| Tulane/LSU Maternal/Child CRS | |
| New Orleans, Louisiana, United States, 701122699 | |
| United States, New York | |
| Bronx-Lebanon Hosp. IMPAACT CRS | |
| Bronx, New York, United States, 10457 | |
| United States, North Carolina | |
| DUMC Ped. CRS | |
| Durham, North Carolina, United States, 277103499 | |
| United States, Tennessee | |
| St. Jude/UTHSC CRS | |
| Memphis, Tennessee, United States, 381052794 | |
| United States, Texas | |
| Texas Children's Hosp. CRS | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Kline M | ||
| Study Chair: | Van Dyke R | ||
| Study Chair: | Yogev R | ||
| Study Chair: | Shenep J |
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000865 History of Changes |
| Other Study ID Numbers: |
ACTG 330 11302 ( Registry Identifier: DAIDS ES ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | February 16, 2012 |
| Last Verified: | February 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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Drug Therapy, Combination Reverse Transcriptase Inhibitors Anti-HIV Agents |
Additional relevant MeSH terms:
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Infection HIV Infections Acquired Immunodeficiency Syndrome 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 Lamivudine |
Zidovudine Abacavir Stavudine Didanosine Anti-Retroviral Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites |