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The Safety and Effects of 1592U89 Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Infants and Children Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about The Safety and Effects of 1592U89 Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Infants and Children conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. The Safety and Effects of 1592U89 Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Infants and Children Clinical research trials and The Safety and Effects of 1592U89 Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Infants and Children healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as The Safety and Effects of 1592U89 Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Infants and Children. The Safety and Effects of 1592U89 Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Infants and Children Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a The Safety and Effects of 1592U89 Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Infants and Children clinical trial. Subjects frequently obtain the most expert healthcare possible for their The Safety and Effects of 1592U89 Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Infants and Children condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The Safety and Effects of 1592U89 Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Infants and Children  The Safety and Effects of 1592U89 Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Infants and Children
The Safety and Effects of 1592U89 Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Infants and Children
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 3 Months/13 Years
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 32
Location and Contact Information:
Overall Study Official:
KlineM, Study Chair,
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Additional Information:
Study ID Numbers: ACTG 330;
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000865
Other Hiv Infections Studies:
1. A Study of Viracept in HIV-Positive Women
2. Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals
3. The Safety and Effectiveness of Two Forms of Saquinavir Combined with Other Anti-HIV Drugs in HIV-Infected Infants and Children
4. The 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
5. The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms
Related Studies:
Other HIV Infections Clinical Trials
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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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