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A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive 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 A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children Clinical research trials and A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive 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 A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children. A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive 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 A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children clinical trial. Human subjects often get the best healthcare available for their A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive 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 > "A" Clinical Trials Conditions > A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children  A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children
A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with other anti-HIV drugs. SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is still needed about SQV-SGC in children. Recent studies suggest that this soft-gel capsule form may be safer and more effective than other protease inhibitors.
Details: Clinical trials in adults and children suggest that SQV-SGC has advantages over other protease inhibitors in terms of tolerability, safety, and effectiveness in patients who have failed therapy with other protease inhibitors. [AS PER AMENDMENT 11/24/99: Pharmacokinetic data from this study demonstrate lower than expected plasma SQV exposures, particularly in Arm 1. Based on these data, patients in the study will be offered the opportunity to adjust their doses. Ritonavir added to the Arm 1 regimen is expected to significantly increase SQV-SGC plasma levels and allow twice-daily dosing for SQV-SGC.] Patients are randomized to one of two study arms. Patients in Arm 1 receive SQV-SGC plus two [AS PER AMENDMENT 11/24/99: one or two] NRTIs of choice. Patients in Arm 2 receive SQV-SGC plus NFV plus one or two NRTIs of choice. All participants are evaluated by physical examinations and laboratory tests during the study and are followed for incidence of death, cancer, or fetal abnormality. NRTIs are not provided as part of this study. [AS PER AMENDMENT 11/24/99: This study is closed to accrual. All subjects on follow-up (Cohort 1) are given the option of either discontinuing participation in ACTG 397 or participating in the next phase of the study (version 2.0). Those electing to continue participation constitute Cohort 1A. The adjusted Arm 1 regimen consists of SQV-SGC plus ritonavir plus one or two NRTIs. Ritonavir is not provided as part of this study. The Arm 2 regimen study drugs have not changed but the maximum allowable dose of SQV-SGC has increased from 1,200 mg twice-daily to 1,600 mg twice-daily. Participants continue to be followed with physical examinations and laboratory evaluations that include an intensive pharmacokinetics study on Day 14 of the new regimen.]
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 3 Years/16 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Your child may be eligible for this study if he or she: - Is HIV-positive. - Is 3 to 16 years of age (consent of parent or guardian is required). - Has an HIV level greater than 10,000 copies/ml. - Has never taken at least one of the following anti-HIV drugs: lamivudine, zidovudine, stavudine, or didanosine. - Is able to swallow capsules and tablets. Exclusion Criteria Your child will not be eligible if he or she: - Has cancer requiring chemotherapy. - Has an acute opportunistic (AIDS-related) infection requiring therapy. - Has had two or more episodes of moderate or severe diarrhea or vomiting in the 3 months prior to study entry. - Has ever taken SQV or NFV. - Is pregnant or breast-feeding. - Is taking certain medications, including those that would interfere with the study drugs.
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
MarkKline, Study Chair,
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Med College of Virginia
Richmond, Virginia, 23219
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Harlem Hosp Ctr
New York City, New York, 10037
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Palm Beach County Health Dept
Riviera Beach, Florida, 33404
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ of Alabama at Birmingham / Childrens Hosp of AL
Birmingham, Alabama, 352330011
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Additional Information:
Study ID Numbers: ACTG 397;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000913
Other Hiv Infections Studies:
1. A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
2. The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections
3. HIV-Related Peripheral Neuropathy
4. Screening Protocol for HIV Vaccine Studies
5. Preventing Sexual Transmission of HIV With Anti-HIV Drugs
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Great Neck Clinical Trials
A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children
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