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Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens



Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens

For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: The purpose of this study is to see if it is safe and effective to give HIV-infected children and teens 1 of 4 anti-HIV drug combinations. Decreasing HIV levels in infected patients can slow down disease progression. Further study is needed to find out which drug combinations are most effective in doing this.
Details: For PRAM 2: Evidence suggests that as a consequence of antiviral therapy, decreases in plasma HIV-1 RNA are strongly associated with a delay in clinical progression. Therefore, the drug regimens proposed in this study are designed to result in a much larger sustained drop in plasma HIV-1 RNA and greater clinical benefit. Further intent of this study is to evaluate the virologic and therapeutic potential of novel combinations of antiretrovirals and to better define the pharmacokinetics and drug-drug interactions of therapies included in this regimen. The Master PRAM schema is designed to allow new therapeutic arms to be studied as "rolling screens" through multiple generations of PRAMs. There is a common, "linking" regimen between any 2 sequential PRAM generations that will permit an indirect comparison of included therapies. (NOTE: Due to significant changes in study design between PRAM 1 and PRAM 2, there is no "linking" arm between them. The linkage will be reinstated from PRAM 2 and subsequent PRAM generations.) The therapeutic potential of the treatment arms is assessed by their ability to decrease HIV copy numbers as defined by plasma HIV-1 RNA copy number. Once accrual to a PRAM is complete, a new treatment comparison will open for accrual. For PRAM 2: This study will compare the following 4 treatment arms: Arm A - stavudine (d4T)/nevirapine/ritonavir Arm B - d4T/lamivudine (3TC)/nelfinavir Arm C - d4T/nevirapine/nelfinavir Arm D - d4T/3TC/nevirapine/nelfinavir. Prior to randomization to 1 of the PRAM 2 treatment arms, patients are stratified based on their CD4% (less than 25% and greater than or equal to 25%) and by age (less than 24 months and greater than or equal to 24 months). The first 35 subjects/treatment arm are evaluated with special immunologic studies including lymphoproliferative assays and extended panel immunophenotyping. There is an interim analysis after all patients have completed 12 weeks of treatment. Patients are treated for 48 weeks. [AS PER AMENDMENT 6/11/99: The study has been extended for an additional 48 weeks (96 weeks total) to permit long-term follow-up of clinically stable, HIV-infected children.]
Eligibility:
Study Type:
  Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 4 Months/17 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have received the same continuous anti-HIV treatment for the past 16 weeks (missing no more than 6 weeks of treatment total during those 16 weeks). - Are between 4 months and 17 years old (consent of parent or guardian required). Exclusion Criteria Patients will not be eligible if they: - Have certain serious conditions such as cancer, an opportunistic (AIDS-related) infection, or other serious infection. - Have ever taken any of the study drugs or any protease inhibitor. - Are currently taking any anti-HIV drugs. - Have taken an investigational drug within 14 days of entry into the study. (Co-enrollment in ACTG 219, ACTG 220 and certain ACTG opportunistic infection studies is allowed.) - Are taking certain other drugs. - Are pregnant.
Total Enrollment: 200

Location and Contact Information:

Overall Study Official:
AndrewWiznia,  Study Chair, 

Children's Hosp of Philadelphia
Philadelphia,  Pennsylvania,  191044318
United States
 

Children's Hospital & Medical Center / Seattle ACTU
Seattle,  Washington,  981050371
United States
 

Bronx Lebanon Hosp Ctr
Bronx,  New York,  10457
United States
 

Howard Univ Hosp
Washington D.C.,  District of Columbia,  20060
United States
 

Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City,  New York,  10032
United States
 

Connecticut Children's Med Ctr - Pediatric
Hartford,  Connecticut,  06106
United States
 

Univ of Massachusetts Med School
Worcester,  Massachusetts,  016550001
United States
 

Palm Beach County Health Dept
Riviera Beach,  Florida,  33404
United States
 

North Broward Hosp District
Ft. Lauderdale,  Florida,  33311
United States
 

Univ of Florida Health Science Ctr / Pediatrics
Jacksonville,  Florida,  32209
United States
 

Columbia Presbyterian Med Ctr
New York City,  New York,  10032
United States
 

SUNY - Brooklyn
Brooklyn,  New York,  11203
United States
 

San Juan City Hosp
San Juan,  ,  009367344
Puerto Rico
 

Schneider Children's Hosp
New Hyde Park,  New York,  11040
United States
 

Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles,  California,  900276016
United States
 

Univ of Alabama at Birmingham - Pediatric
Birmingham,  Alabama,  35233
United States
 

North Shore Univ Hosp
Great Neck,  New York,  11021
United States
 

Johns Hopkins Hosp - Pediatric
Baltimore,  Maryland,  212874933
United States
 

Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore,  Maryland,  21201
United States
 

Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark,  New Jersey,  07103
United States
 

Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon,  ,  00956
Puerto Rico
 

UCSF / Moffitt Hosp - Pediatric
San Francisco,  California,  941430105
United States
 

Tulane Univ / Charity Hosp of New Orleans
New Orleans,  Louisiana,  701122699
United States
 

Harlem Hosp Ctr
New York City,  New York,  10037
United States
 

Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr
Bronx,  New York,  10461
United States
 

Washington Hosp Ctr
Washington D.C.,  District of Columbia,  200102931
United States
 

UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla,  California,  920930672
United States
 

Children's Hosp of Oakland
Oakland,  California,  946091809
United States
 

Med Univ of South Carolina
Charleston,  South Carolina,  294253312
United States
 

Med College of Georgia
Augusta,  Georgia,  30912
United States
 

Chicago Children's Memorial Hosp
Chicago,  Illinois,  606143394
United States
 

UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick,  New Jersey,  089030019
United States
 

Metropolitan Hosp Ctr
New York City,  New York,  10029
United States
 

Vanderbilt Univ Med Ctr
Nashville,  Tennessee,  372322581
United States
 

Cornell Univ Med College
New York City,  New York,  10021
United States
 

Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles,  California,  905022004
United States
 

Saint Christopher's Hosp for Children
Philadelphia,  Pennsylvania,  191341095
United States
 

Yale Univ Med School
New Haven,  Connecticut,  06504
United States
 

Univ of Illinois College of Medicine / Pediatrics
Chicago,  Illinois,  60612
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
 

Cook County Hosp
Chicago,  Illinois,  60612
United States
 

Los Angeles County - USC Med Ctr
Los Angeles,  California,  90033
United States
 

Long Beach Memorial (Pediatric)
Long Beach,  California,  90801
United States
 

Emory Univ Hosp / Pediatrics
Atlanta,  Georgia,  30306
United States
 

State Univ of New York at Stony Brook
Stony Brook,  New York,  117948111
United States
 

UCLA Med Ctr / Pediatric
Los Angeles,  California,  900951752
United States
 

Children's Hosp of Washington DC
Washington D.C.,  District of Columbia,  200102916
United States
 

Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx,  New York,  10461
United States
 

King's County Hosp Ctr / Pediatrics
Brooklyn,  New York,  11203
United States
 

Univ of Chicago Children's Hosp
Chicago,  Illinois,  606371470
United States
 

Children's Hosp of the King's Daughters
Norfolk,  Virginia,  23507
United States
 

Baystate Med Ctr of Springfield
Springfield,  Massachusetts,  01199
United States
 

Univ of Florida Gainesville
Gainesville,  Florida,  32610
United States
 

Univ of Mississippi Med Ctr
Jackson,  Mississippi,  39213
United States
 


Additional Information:
Study ID Numbers:
  ACTG 377;  PACTG 377
Study Start Date: 
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001091

Other Hiv Infections Studies:
1. SU5416 in Patients with AIDS-Related Kaposi's Sarcoma

2. A Study of 1592U89 in HIV-Infected Children

3. A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma

4. A Phase I Trial of APL 400-003 Vaccine: Safety and Immune Response Evaluations of Multiple Injections at Escalating Doses in Asymptomatic HIV-Infected Patients

5. A Study of Two Anti-HIV Drug Combinations in HIV-Infected Patients

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Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens

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