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Home > "C" Clinical Trials Conditions > Comparison of New Anti-HIV Drug Combinations in HIV-Infected Children Who Have Taken Anti-HIV Drugs  Comparison of New Anti-HIV Drug Combinations in HIV-Infected Children Who Have Taken Anti-HIV Drugs
Comparison of New Anti-HIV Drug Combinations in HIV-Infected Children Who Have Taken Anti-HIV Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: For PRAM-1: To evaluate zidovudine (ZDV) + lamivudine (3TC) vs. stavudine (d4T) + ritonavir vs. ZDV + 3TC + ritonavir with respect to the change in plasma HIV-1 RNA copy number from baseline to 48 weeks [AS PER AMENDMENT 1/5/98: 72 weeks; AS PER AMENDMENT 7/17/98: 48 weeks] in stable HIV-infected children with >= 16 weeks of prior continuous antiretroviral therapy. To evaluate the safety and tolerance of ZDV + 3TC vs. d4T + ritonavir vs. ZDV + 3TC + ritonavir based upon laboratory and clinical toxicities. AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2: To evaluate d4T + nevirapine + ritonavir with respect to change in plasma HIV-1 RNA copy number from baseline to 48 weeks in children who have received at least 12 weeks of therapy on the PRAM-1 ZDV/3TC arm and have over 10,000 viral copies at weeks 12, 24, or 36. To evaluate the safety and tolerance of d4T + nevirapine + ritonavir based upon laboratory and clinical toxicities. [AS PER AMENDMENT 10/23/98: To evaluate safety and tolerance of a switch from d4T + ritonavir vs. ZDV + 3TC + ritonavir to d4T + indinavir vs. ZDV + 3TC + indinavir in stable, HIV-infected children with RNA values <= 10,000 copies/ml.] For PRAM-1: Evidence supports combination therapy with 2 or more antiviral agents as beneficial in the long-term management of HIV. The possibility exists that combination therapy may result in a synergistic or additive activity over a prolonged period of time. Also hypothesized is that the development of resistance to individual agents will be developed if viral replication is significantly decreased. AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2: Interim analysis at 12 weeks on PRAM-1 indicates that the proportion of children reaching undetectable RNA levels on the ZDV + 3TC arm is significantly less than the other two arms. The protocol, therefore, has been modified (Step 2) to permit children in the ZDV + 3TC arm with RNA copy number >= 10,000 the opportunity to change to a novel therapeutic regimen (d4T + nevirapine + ritonavir).
Details: For PRAM-1: Evidence supports combination therapy with 2 or more antiviral agents as beneficial in the long-term management of HIV. The possibility exists that combination therapy may result in a synergistic or additive activity over a prolonged period of time. Also hypothesized is that the development of resistance to individual agents will be developed if viral replication is significantly decreased. AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2: Interim analysis at 12 weeks on PRAM-1 indicates that the proportion of children reaching undetectable RNA levels on the ZDV + 3TC arm is significantly less than the other two arms. The protocol, therefore, has been modified (Step 2) to permit children in the ZDV + 3TC arm with RNA copy number >= 10,000 the opportunity to change to a novel therapeutic regimen (d4T + nevirapine + ritonavir). The Master PRAM is a Phase II, multicenter, randomized, open-label trial of a standard therapeutic regimen in current use versus experimental therapies administered over 48 weeks. It is designed to allow new therapeutic arms to be studied as "rolling screens" through multiple generations of PRAM. Each PRAM generation compares 2 novel therapeutic arms with a linking arm that allows for an indirect comparison of included therapies. Once accrual to PRAM-1 is complete a new treatment comparison opens for accrual (PRAM-2). The linking arm to be used in PRAM-2 is decided by the Pediatric Primary Scientific Committee. PRAM-2 will continue to accrue patients while PRAM-1 patients continue therapy. For PRAM-1: This study compares the following three treatment arms: Arm I: ZDV plus 3TC Arm II: d4T plus ritonavir Arm III: ZDV plus 3TC plus ritonavir. Prior to randomization to one of the three arms, patients are stratified based on CD4 percents: either less than 15% or greater than or equal to 15%. The first 8 patients randomized to Arms II and III participate in a real-time Phase I pharmacokinetic study (16 patients total). After the first 45 (15 per arm) patients entered are followed for 24 weeks, an interim analysis is done. Patients are treated for 48 weeks [AS PER AMENDMENT 1/5/98: 72 weeks]. AS PER AMENDMENT 10/20/97: PRAM-1, Step 2: Patients initially assigned to Arm I (ZDV plus 3TC) who have RNA values greater than 10,000 copies at week 12, 24, or 36 are assigned to switch protocol treatment to d4T + ritonavir + nevirapine. Patients may enroll in Step 2 no later than week 38 of PRAM-1. [AS PER AMENDMENT 1/5/98: Patients initially assigned to Arm 1 with viral load greater than 100,000 copies may also switch to Step 2 or discontinue therapy. Patients originally assigned to Arms I or II with viral load greater than 10,000 may continue their current drugs or discontinue study therapy; those with viral load greater than 100,000 should discontinue study drugs.] [AS PER AMENDMENT 7/17/98: PRAM-1 has been extended to permit long-term follow-up of clinically stable, HIV-infected children for a total of 120 weeks. Patients still on initial treatment assignment for all three treatment arms are eligible for this extension, as are children from PRAM-1, Step 2. Step 2 is now closed to enrollment. Patients on 3TC/ZDV who reach virologic failure must discontinue study therapy]. [AS PER AMENDMENT 10/23/98: PRAM-1, Step 3: This amendment substitutes indinavir (IDV) capsules for ritonavir capsules in PRAM-1. The regimens will switch from d4T plus ritonavir versus ZDV plus 3TC plus ritonavir to d4T plus IDV versus ZDV plus 3TC plus IDV. All patients will be followed for 48 weeks. Patients eligible for this change in regimens are those taking ritonavir capsules who have RNA values less than or equal to 10,000 copies/ml (as demonstrated by the most recent viral load test) after at least 72 weeks on PRAM-1, Step I. Twelve patients with RNA values less than or equal to 400 copies/ml will immediately join the study; 6 will receive d4T plus IDV and 6 will receive ZDV plus 3TC plus IDV. Additional patients may be added based on toxicity and viral load results. A total sample size of 53 evaluable patients (37 with RNA values less than or equal to 400 copies/ml and 16 with RNA values of greater than 400 to 10,000 copies/ml) is anticipated. PRAM-1 Step 2 patients are not eligible for Step 3. PRAM-1, Step 2 patients currently taking liquid ritonavir should continue their study drug; those taking ritonavir capsules will switch to liquid ritonavir or go off study.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 2 Years/17 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - IVIG and opportunistic infection prophylaxis will be allowed. - Erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony- stimulating factor (GM-CSF) will be allowed for the management of hematologic toxicity. - Treatment with trimethoprim is allowed at the discretion of the principal investigator. Patients must have: - Laboratory evidence (at least 2 viral tests) of HIV-1 infection. - Clinical and immunological stability [maintained CDC category 1 or 2 immunologic status for past 4 months and no new CDC category (diagnosis within the past year)]. - Patients must have received continuous antiretroviral therapy for the past 16 weeks (missing no more than 6 weeks of therapy during the previous 16 weeks). AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2: - Viral load >= 10,000 and < 100,000 copies/ml at week 12, 24, or 36 in children initially assigned to Arm I (ZDV + 3TC) of PRAM-1 and currently on study. Prior Medication: Required: - Patients must have received continuous antiretroviral therapy for the past 16 weeks. Allowed: - Patients who have received immunomodulator therapy as part of perinatal clinical trials or in trials for HIV- exposed infants are eligible. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Current grade 3/4 clinical or laboratory toxicity and/or current grade 2 or higher amylase/lipase toxicity. - Active opportunistic infection and/or serious bacterial infection. - Current diagnosis of malignancy. Concurrent Medication: Excluded: - Current antiretroviral therapy identical to any of the following regimens: - ZDV + 3TC, d4T + ritonavir and ZDV + 3TC + ritonavir. - Concurrent therapy with any other anti-HIV-1 therapy, biologic response modifiers (EPO, G-CSF and GM-CSF allowed), human growth hormone and megestrol acetate. - Use of continuous systemic corticosteroids (>= 14 days duration) is not allowed. - Medications that are incompatible with ritonavir. - Probenecid and daily intravenous pentamidine. [AS PER AMENDMENT 10/23/98: The following are excluded in patients receiving indinavir: - terfenadine, astemizole, cisapride, rifampin, rifabutin, triazolam, ketoconazole, clarithromycin, carbamazepine, phenobarbital, phenytoin, calcium channel blockers, midazolam, and ergot derivatives.] Patients with the following prior conditions and symptoms are excluded: - Documented hypersensitivity to a therapy included in any of the treatment arms. Prior Medication: Excluded: Investigational drug therapy within 2 weeks prior to randomization. NOTE: - Co-enrollment in ACTG 219, ACTG 220 and certain ACTG opportunistic infection protocols is allowed.
Total Enrollment: 240
Location and Contact Information:
Overall Study Official:
NachmanS, Study Chair,
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Palm Beach County Health Dept
Riviera Beach, Florida, 33404
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Univ of Florida Gainesville
Gainesville, Florida, 32610
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Westchester Hosp
Valhalla, New York, 10595
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Med College of Virginia
Richmond, Virginia, 23219
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
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, 11203
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Additional Information:
Study ID Numbers: ACTG 338;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001083
Other Hiv Infections Studies:
1. Comparison of 2',3'-Dideoxyinosine (Didanosine, ddI) and Zidovudine in Therapy of Patients With the AIDS Dementia Complex
2. A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)
3. A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
4. Growth Hormone Treatment of Children with HIV-Associated Growth Failure
5. A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn)
Related Studies:
Other HIV Infections Clinical Trials
Other Connecticut Clinical Trials
Other New Haven Clinical Trials
Comparison of New Anti-HIV Drug Combinations in HIV-Infected Children Who Have Taken Anti-HIV Drugs
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