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The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used with and without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used with and without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used with and without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs Clinical research trials and The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used with and without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used with and without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs. The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used with and without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used with and without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs clinical trial. Subjects often receive the most expert healthcare possible for their The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used with and without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used with and without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs  The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used with and without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs
The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used with and without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: To compare the safety, tolerance, durability of the viral load response and the antiviral activity of the 1592U89/zidovudine(ZDV)/lamivudine (3TC) regimen vs. ZDV/3TC regimen. To determine the clinical efficacy of the two regimens as measured survival, disease progression, weight growth velocity, and neuropsychological or neurological changes. To assess the development of viral resistance and relative pharmacokinetics associated with each regimen.
Details: Patients are randomized to receive blinded treatment with ZDV/3TC alone or in combination with 1592U89, orally for 16 weeks. If after the 16-week period certain criteria are met, patients may have the option to switch to open-label treatment for the remainder of the study period.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 3 Months/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Intravenous immunoglobulin G, erythropoietin, G-CSF and GM-CSF. - Opportunistic infection prophylaxis. Patients must have: - HIV-1 infection documented by: < 18 months of age: - one positive viral test culture and one other positive viral test (culture, PCR, p24 antigen, or Immune Complex Dissociation p24 antigen) on two different specimens. >= 18 months of age: - two positive viral tests as stated above, one or both of which may be determined by a federally documented ELISA and confirmed by Western blot or Indirect Fluorescent Antibody test. - Any of the CDC Categories: - 1, 2, 3, and N, A, B, and C of the 1994 Revised Classification System for HIV Infection in Children Less than 13 Years of Age. - CD4+ count >= 15% within 14 days prior to study drug administration. - No active or ongoing AIDS-defining opportunistic infection that precludes absorption of study drug or observation of a study parameter. - Signed, informed consent from parent or legal guardian for patients under 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Serious bacterial infection that precludes absorption of study drug or observation of a study parameter. - Documented hypersensitivity to a nucleoside analog. - Co-enrollment in certain opportunistic infection protocols is not exclusionary if approval is obtained. - Malignancy. - Life-threatening infection or other chronic disease that may compromise patient safety. - Grade 3/4 clinical or laboratory toxicity or current grade 2 or higher pancreatic amylase or lipase toxicity as defined by the ACTG Toxicity Tables within 14 days prior to study entry. Concurrent Medication: Excluded: - Other anti-HIV therapy. - Probenecid. - Biologic response modifier (unless listed under included concurrent medication) and megestrol acetate. - Human growth hormone. - Immunomodulators and cytotoxic chemotherapeutic agents. - Systemic corticosteroids > 14 days without approval. - Investigational agents. Concurrent Treatment: Excluded: Radiation therapy. Patients with the following prior conditions are excluded: - History of clinically relevant pancreatitis or hepatitis within the past 6 months. - Participation in a vaccine trial. Prior Medication: Excluded: - Protease inhibitor therapy within 2 weeks prior to randomization. - Interleukins or interferons within 30 days prior to study drug administration. - Investigational drugs within 14 days prior to randomization. - HIV vaccine dose within past 30 days. Required: > 12 weeks prior antiretroviral therapy and unchanged therapy 12 weeks prior to screening.
Total Enrollment:
Location and Contact Information:
Univ of Florida - Gainesville / Infectious Dis & Immun
Gainesville, Florida, 326100296
United States
PACT Program
Buffalo, New York, 14222
United States
Children's Diagnostic Treatment Ctr
Ft. Lauderdale, Florida, 33301
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
UMDNJ / Division of Allergy Immunology & Infectious Diseases
Newark, New Jersey, 07103
United States
Univ of Miami / Fox Cancer Research Ctr
Miami, Florida, 33136
United States
SUNY Health Sciences Ctr at Syracuse / Dept of Pediatrics
Syracuse, New York, 13210
United States
Univ of Minnesota Med School
Minneapolis, Minnesota, 55455
United States
SUNY Health Ctr at Stony Brook / Pediatric Infectious Dis
Stony Brook, New York, 117948111
United States
Arnold Palmer Hosp for Women and Children
Orlando, Florida, 32806
United States
St Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Children's Hosp Los Angeles
Los Angeles, California, 90027
United States
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 78284
United States
The Children's Med Ctr / Division of Infectious Dis
Dayton, Ohio, 454041815
United States
New York Hosp - Cornell / Program for Children with AIDS
New York City, New York, 10021
United States
Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608
United States
Bronx Lebanon Hosp Ctr / Dept of Pediatrics
Bronx, New York, 10457
United States
Duke Univ Med Ctr / Pediatrics Dept / Infec Dis
Durham, North Carolina, 27710
United States
North Shore Univ Hosp / Pediatric Immunology
Great Neck, New York, 11021
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Univ of South Florida All Children's Hosp
Saint Petersburg, Florida, 33701
United States
Cook's Ft Worth Children Med Ctr / Pediatric Inf Dis
Ft. Worth, Texas, 76104
United States
Eastern VA Med Sch / Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
United States
Pediatric Special Immunology Clinic / HRS / PBC PHU
Riviera Beach, Florida, 33404
United States
Children's Med Ctr of Dallas / ARMS Clinic
Dallas, Texas, 75235
United States
Dr Patricia Emmanuel
Tampa, Florida, 33606
United States
Univ Alabama - Birmingham / Dept of Pediatrics / UAB Station
Birmingham, Alabama, 35294
United States
Univ of North Carolina / Pediatric Infectious Diseases
Chapel Hill, North Carolina, 27514
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Additional Information:
Study ID Numbers: 238L; CNAA3006
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002391
Other Hiv Infections Studies:
1. A Study of Two Forms of Pentamidine in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
2. Valganciclovir in Patients with CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
3. The Effect of Oral Candidiasis on the Speech Production, Feeding Skills, and Self-Concept of Children and Adolescents with Symptomatic HIV Infection
4. Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
5. The Effects of r-metHuIFN-gamma on the Lungs of Patients with AIDS
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The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used with and without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs
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