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The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children Clinical research trials and The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children. The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children clinical trial. Human subjects often get the best healthcare available for their The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children  The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children
The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Glaxo Wellcome
Synopsis: To evaluate and compare differences in tolerance and side effects associated with two different dosages of zidovudine (AZT) when used to treat children with HIV infection. Other goals are to evaluate and compare the degree of change in neurodevelopmental disease and determine whether there are differences in the rate and degree of toxicities associated with one versus the other dosage. AZT has been shown to decrease the death rate and frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. Thus, it is likely that symptomatic HIV infected children may also benefit from AZT. Studies of the safety and pharmacokinetics (blood levels) in children have indicated that AZT can be given to children in doses that can be tolerated and that can be assumed to be therapeutic. Those currently taking care of infected children no longer feel it is ethical to conduct an AZT/placebo (inactive substance) trial. In addition, given the information learned from studies of adult patients that shows effectiveness of AZT at lower doses, experience with an equivalent lower dose in children needs to be studied.
Details: AZT has been shown to decrease the death rate and frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. Thus, it is likely that symptomatic HIV infected children may also benefit from AZT. Studies of the safety and pharmacokinetics (blood levels) in children have indicated that AZT can be given to children in doses that can be tolerated and that can be assumed to be therapeutic. Those currently taking care of infected children no longer feel it is ethical to conduct an AZT/placebo (inactive substance) trial. In addition, given the information learned from studies of adult patients that shows effectiveness of AZT at lower doses, experience with an equivalent lower dose in children needs to be studied. All participants are randomized to receive AZT at 1 of 2 doses. Patients are stratified according to whether CD4 cell counts are > or < 500 cells/mm3 as well as whether symptoms are mild to moderate or if patients have lymphocytic interstitial pneumonitis (LIP). Medication is dispensed every other week for the first 8 weeks and monthly until week 104, then either monthly or every 3 months. Safety and effectiveness of the treatment program are evaluated at 6-month intervals to assess whether it is appropriate to continue the study as originally designed. Patients are evaluated every 2 weeks for the first 8 weeks, monthly until week 104, every 3 months until week 208, and then every 6 months thereafter.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Months/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: AMENDED: - 03-19-91 Prophylaxis for PCP is recommended according to current practice guidelines. As per published recommendations, primary prophylaxis with TMP / SMX on a M-T-W basis is encouraged. Allowed: - Immunoglobulin therapy as single dose exposure prophylaxis or for children with hypogammaglobulinemia. - Trimethoprim / sulfamethoxazole (TMP / SMX) and parenteral or aerosolized pentamidine for prophylaxis for Pneumocystis carinii pneumonia for children with AIDS and/or CD4+ counts = or < 500 cells/mm3. - Systemic ketoconazole and acyclovir, or oral nystatin for acute therapy. - Aerosol ribavirin for short-term treatment of acute respiratory syncytial virus (RSV). AMENDED: - 9/17/90 enrollment is limited to children < 6 years of age. - Original design: - Patients must have the following: - Parent or guardian available to give written informed consent. - Laboratory evidence of HIV infection. - Children < 15 months of age, with CD4+ cell count > 500 cells/mm3, who are thought to have acquired HIV through perinatal transmission and whose only laboratory evidence of HIV infection is a positive antibody test, must also have one or more of the laboratory criteria described in Disease Status AND one or more of the disease criteria that are required of children > 15 months old with CD4+ cell counts > 500 cells/mm3. Prior Medication: Allowed: - Aerosol ribavirin. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Previous AIDS-defining opportunistic infection or neoplasms as specified by the CDC surveillance criteria for AIDS. - Previous unexplained recurrent, serious bacterial infections (two or more within a 2-year period) including sepsis, meningitis, pneumonia, abscess of an internal organ, and bone/joint infections caused by Haemophilus, Streptococcus, or other pyogenic bacteria. - Qualifying for entrance criteria to zidovudine (AZT) + or - gammaglobulin (ACTG 051). - Encephalopathy. - Failure to thrive (defined as a child who crosses two percentile lines on the growth chart or child who is < fifth percentile and does not follow curve) and/or oral candidiasis for at least 2 months despite appropriate topical therapy. - Lymphocytic interstitial pneumonitis (LIP) with steroid dependency or requiring supplemental oxygen. - Preexisting malignancies. Concurrent Medication: AMENDED: - 03-19-91 Prophylaxis with antiviral or antifungals agents, except for PCP prophylaxis is prohibited. - Drugs that are metabolized by hepatic glucuronidation should be used with caution. Excluded: - Prophylaxis for oral candidiasis or otitis media or other infections (sinusitis, urinary tract infections). - Immunoglobulin therapy not specifically allowed. - Ketoconazole, acyclovir, or nystatin for prophylaxis. - Drugs that are metabolized by hepatic glucuronidation and might alter metabolism of zidovudine (AZT). Patients with the following are excluded: - Previous AIDS-defining opportunistic infection or neoplasms as specified by the CDC surveillance criteria for AIDS. - Previous unexplained recurrent, serious bacterial infections (two or more within a 2-year period) including sepsis, meningitis, pneumonia, abscess of an internal organ, and bone/joint infections caused by Haemophilus, Streptococcus, or other pyogenic bacteria. - Qualifying for entrance criteria to zidovudine (AZT) + or - gammaglobulin (ACTG 051). - Encephalopathy. - Failure to thrive (defined as a child who crosses two percentile lines on the growth chart or child who is < fifth percentile and does not follow curve) and/or oral candidiasis for at least 2 months despite appropriate topical therapy. - Lymphocytic interstitial pneumonitis (LIP) with steroid dependency or requiring supplemental oxygen. - Preexisting malignancies. Prior Medication: Excluded within 2 weeks of study entry: - Any other experimental therapy or drugs that cause prolonged neutropenia or significant nephrotoxicity. Excluded within 1 month of study entry: - Antiretroviral agents. - Immunomodulating agents including immunoglobulin, interferon, isoprinosine, and IL-2. Excluded within 2 months of study entry: - Systemic ribavirin for retroviral therapy. Prior Treatment: Excluded within 1 month of study entry: - Lymphocyte or red blood cell transfusions. Active alcohol or drug abuse.
Total Enrollment: 400
Location and Contact Information:
Overall Study Official:
MBrady, Study Chair,
Univ of Connecticut Health Ctr / Pediatrics
Farmington, Connecticut, 06032
United States
Beth Israel Med Ctr / Pediatrics
New York City, New York, 10003
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Jewish Hosp Ctr of Long Island / Pediatrics
Jamaica, New York, 11432
United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Schneider Children's Hosp / Long Island Jewish Med Ctr
New Hyde Park, New York, 11042
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10456
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Lincoln Hosp Ctr / Pediatrics
Bronx, New York, 10451
United States
Ctr for Special Immunology
Ft. Lauderdale, Florida, 33308
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
UPR Children's Hosp / San Juan City Hosp
San Juan, , 00936
Puerto Rico
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00619
Puerto Rico
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston Salem, North Carolina, 27103
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Northern California Pediatric AIDS Treatment Ctr / UCSF
San Francisco, California, 94143
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15219
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Columbia Univ Babies' Hosp
New York City, New York, 10032
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
Brooklyn, New York, 11203
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Kaiser Permanente / UCLA Med Ctr
Downey, California, 902422814
United States
Westchester Hosp / New York Med College / Pediatrics
Valhalla, New York, 10595
United States
Albert Einstein College of Medicine
Bronx, New York, 10461
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Children's Natl Med Ctr
Washington D.C., District of Columbia, 20010
United States
Univ of Illinois College of Medicine
Chicago, Illinois, 60612
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: ACTG 128;
Study Start Date:
Record last reviewed: March 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000983
Other Hiv Infections Studies:
1. A Study of MKC-442 in HIV-Positive Patients
2. Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
3. A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients
4. Fortovase (Saquinavir) Given with Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns
5. A Treatment Protocol for the Use of Trimetrexate With Leucovorin Rescue for AIDS Patients with Pneumocystis carinii Pneumonia and Serious Intolerance to Approved Therapies
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children
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