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A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV Clinical research trials and A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV. A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV clinical trial. Human subjects often get the best healthcare possible for their A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV  A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV
A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the pharmacokinetics, safety, and efficacy of didanosine (ddI) alone or in combination with zidovudine (AZT) in HIV-infected infants. PER AMENDMENT 4/8/97: Part A study objectives are completed. Part B objectives: To assess the safety, toxicity, and tolerability and to compare anti-HIV activity, as measured by change in log10 RNA, of the two study arms. Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and rapid decline of CD4 count and immunologic function. Combination therapy may be preferred over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is little information on ddI monotherapy in young infants less than 90 days and no information on the use of combination therapy in this population.
Details: Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and rapid decline of CD4 count and immunologic function. Combination therapy may be preferred over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is little information on ddI monotherapy in young infants less than 90 days and no information on the use of combination therapy in this population. In Part A, a cohort of patients younger than 28 days (was less than 120 days; amended 6/20/95) of age receives open-label ddI monotherapy for 1 week before initiation of AZT/ddI combination therapy. After pharmacokinetic data are obtained, an additional cohort of patients receives ddI at a higher dose. An age-adjusted dose for ddI is determined for use in Part B. (NOTE: As of 2/13/95, Part A has completed accrued for infants 29 to 120 days of age.) Part B patients less than 90 days of age (was less than 180 days of age; amended 6/20/95) are randomized, on a double-blind basis, to receive ddI or AZT/ddI. All patients continue treatment until 12 months after the last patient on Part B is enrolled. PER AMENDMENT 4/8/97: Part A of this protocol is closed with accrual objectives met. Part B of the study will remain open for patient accrual until 6/2/97. Part B is designed as a 2-arm, randomized, double-blind study to assess safety, toxicity and tolerability as well as anti-HIV activity of ddI or AZT/ddI.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: /3 Months
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Recommended: - PCP prophylaxis. Allowed: - Acetaminophen if not on a continual basis. NOTE: - Drugs that are metabolized by hepatic glucuronidation or that are associated with occurrence of pancreatitis are allowed but should be used with caution. Patients must have at least one of the following: - Documented HIV infection. - Been born to an HIV-infected woman and receiving AZT. PER AMENDMENT 4/8/97: - Number 2 above no longer required with closure of Part A of study. - Patients must have signed, informed consent of parent or legal guardian. PER 6/20/95 AMENDMENT, patients in Part A must be less than 28 days of age and those in Part B must be less than 90 days of age. PER 7/7/94 AMENDMENT, patients in Part A were less than 120 days of age and those in Part B were less than 180 days of age. NOTE: - All patients must have been more than 34 weeks gestation at birth. Prior Medication: Allowed: - Prior vaccine therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Pancreatitis. - Clinically unstable condition. - Current participation on a vaccine trial or, for Part A, a perinatal trial if of indeterminate infection status. Concurrent Medication: Excluded: - Vaccine therapy. Patients with the following prior condition are excluded: - Pancreatitis at any time since birth. Prior Medication: Excluded in Part B patients only: - More than 90 days of prior antiretroviral or immunomodulator therapy, exclusive of therapy received in utero.
Total Enrollment: 180
Location and Contact Information:
Overall Study Official:
AKovacs, Study Chair,
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Med College of Virginia
Richmond, Virginia, 23219
United States
Palm Beach County Health Dept
Riviera Beach, Florida, 33404
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Additional Information:
Study ID Numbers: ACTG 239;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001049
Other Hiv Infections Studies:
1. A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
2. Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces boulardii or Placebo: A Double Blind Trial
3. Neurodevelopmental and Neurological Study of Infants and Children With HIV-1 Infection and AIDS in Clinical Trials
4. HIV Symptom Management Program for African American Mothers
5. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3
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A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV
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