|
A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment Clinical research trials and A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment. A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment  A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment
A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment
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 value of changing anti-HIV medications in children with progressive HIV disease who have received previous treatment. Plasma viral load (the level of HIV in the blood) is probably most effectively reduced by giving patients anti-HIV drugs which affect the virus at various stages of development. Changing the medications may enhance the results of treatment.
Details: The Master RAD Protocol is based on the concept that optimal suppression of viral load in vivo will be achieved in patients with rapidly progressing or advanced HIV disease (RAD) using antiretroviral combinations inhibiting viral replication at distinct sites of action. Antiretroviral combinations are chosen with the hypothesis that simultaneous change to as many new agents as possible is necessary to maximally reduce plasma viral load. In this open-label, multicenter study patients are randomized into 1 of 4 groups based on prior antiretroviral experience. Each regimen consists of 4 drugs that include a combination of nucleoside reverse transcriptase inhibitors (stavudine, lamivudine, zidovudine, didanosine, zalcitabine) plus nevirapine (NVP), nelfinavir (NFV), or ritonavir (RTV). Patients must be naive to at least 2 of the 4 drugs in the regimen and at least 1 of the novel drugs must be NVP, NFV, or RTV. Prior to randomization to a NFV- or RTV-containing regimen, patients are stratified by HIV RNA (greater than or equal to 50,000 or less than 50,000) and must able to receive 2 or more novel drugs.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 6 Months/21 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Your child may be eligible for this study if he or she: - Is HIV-positive. - Is between the ages of 6 months and 21 years (consent of parent or guardian required if under 18). - Has an HIV blood level above 50,000 copies/mL on 2 consecutive occasions, while taking anti-HIV therapy. - Has advanced HIV disease or disease progression while receiving 8 weeks or more of continuous unchanged anti-HIV therapy. - Is able to receive at least one of the following: RTV, NVP, or NFV. Exclusion Criteria Your child will not be eligible for this study if he or she: - Is receiving treatment for a serious bacterial, viral, or opportunistic (HIV-associated) infection within 14 days prior to study entry. - Has a history of pancreatitis or peripheral neuropathy. - Has cancer requiring chemotherapy. - Is allergic to the study medications. - Is taking certain medications. - Is pregnant.
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
AndreaKovacs, Study Chair,
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
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
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ of South Alabama
Mobile, Alabama, 36604
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 372322581
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
The Med Ctr Inc
Columbus, Georgia, 31901
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Med College of Virginia
Richmond, Virginia, 23219
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001
United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Additional Information:
Study ID Numbers: ACTG 366;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000902
Other Hiv Infections Studies:
1. A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy
2. A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy
3. A Study to Evaluate the Safety and Effectiveness of a New Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), (+)-Calanolide A, in HIV-Positive Patients Who Have Never Received Anti-HIV Treatment
4. The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection
5. Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment
|
|
|
|
|
|
|
|
