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NCT00000924 Clinical Trial

A Study to Compare Two Different Anti-HIV Drug Regimens

HIV Infections Clinical Trial

Official title:
A Phase II Randomized, Multicenter Protocol Evaluating Two Antiretroviral Regimens Containing Combinations of Protease Inhibitors, NRTIs, and an NNRTI

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000924
Other study ID # ACTG 403
Secondary ID 11358P1001S (sub
Status Completed
Phase Phase 2
First received
Last updated
Est. completion date June 2001

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study compares 2 different anti-HIV drug regimens to determine which is the most effective in lowering the amount of HIV in the blood. The anti-HIV drugs used in this study are 2 protease inhibitors (nelfinavir and ritonavir), 2 nucleoside reverse transcriptase inhibitors (stavudine and didanosine), and 1 nonnucleoside reverse transcriptase inhibitor (nevirapine). These drug combinations have been previously studied in adults, but there is limited information on how well they work in HIV-infected children. It is important to develop drug combinations which are effective at suppressing the HIV virus in children.

Description:

The use of combination therapy with 2 or more antiretroviral agents has been strongly supported by recent studies in both children and adults. However, as of yet, few combinations of antiretrovirals have been studied in large cohorts of stable HIV-1 infected, antiretroviral-experienced children. Evidence suggests that viral suppression may be more difficult to achieve in children. Therefore, it is important to develop new drug combinations which can maximally suppress plasma HIV-1 RNA concentrations in children. Patients are stratified by prior antiretroviral treatment (zidovudine [ZDV]/lamivudine [3TC] versus d4T/other treatment) and by age (under 24 months versus 24 months and older). Patients are then randomized to 1 of 4 treatment groups. Arm A1: ddI/NFV/RTV (for prior ZDV/3TC-treated patients). Arm A2: ddI/NFV/RTV (for prior d4T/other-treated patients). Arm B1: d4T/NFV/NVP (for prior ZDV/3TC-treated patients). Arm B2: d4T/NFV/NVP (for prior d4T/other-treated patients). Treatment is administered for 48 weeks. At Weeks 2, 4, and then every 4 weeks thereafter, patients undergo physical examinations, and blood samples are drawn to measure viral load. [AS PER AMENDMENT 4/27/00: Patients in Arms A1 and A2 may continue to receive medication for an additional 24 weeks. While on the treatment extension, patients must continue their current schedule for study drug administration and completion of study visits. Patients in Arms A1 and A2 who have reached Week 44 participate in an enteric-coated ddI pharmacokinetic study as part of this 24-week extension. Patients who were enrolled in Arms A1 or A2 and who were taken off study after reaching Week 48 may be re-entered onto the study at Week 52 regardless of the number of weeks they have been off study.]

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date June 2001
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 4 Months to 21 Years
Eligibility Inclusion Criteria Patients may be eligible for this study if they: - Are between 4 months and 21 years of age (consent of parent or guardian required if under 18). - Are HIV-positive. - Have a viral level of at least 4,000 copies/ml. - Have a CD4 cell count of at least 750 (under 12 months of age), at least 500 (1 to 5 years of age), or at least 200 (6 years of age or older) cells/mm3 within the past 4 months or a CD4 percent of 15 percent or higher within the past 4 months. - Have received the same continuous antiretroviral therapy for the past 16 weeks. Exclusion Criteria Patients will not be eligible for this study if they: - Have an active opportunistic and/or serious bacterial infection. - Have been diagnosed with a malignancy. - Have received prior treatment with certain antiretroviral medications. - Are pregnant or breast-feeding.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ritonavir

• Nelfinavir mesylate

• Nevirapine

• Stavudine

• Didanosine

Locations
Country Name City State
Puerto Rico Ramon Ruiz Arnau Univ Hosp / Pediatrics Bayamon
Puerto Rico San Juan City Hosp San Juan
Puerto Rico Univ of Puerto Rico / Univ Children's Hosp AIDS San Juan
United States Emory Univ Hosp / Pediatrics Atlanta Georgia
United States Johns Hopkins Hosp - Pediatric Baltimore Maryland
United States Univ of Maryland at Baltimore / Univ Med Ctr Baltimore Maryland
United States Univ of Alabama at Birmingham - Pediatric Birmingham Alabama
United States Children's Hosp of Boston Boston Massachusetts
United States Bronx Lebanon Hosp Ctr Bronx New York
United States Bronx Municipal Hosp Ctr/Jacobi Med Ctr Bronx New York
United States Med Univ of South Carolina Charleston South Carolina
United States Chicago Children's Memorial Hosp Chicago Illinois
United States Cook County Hosp Chicago Illinois
United States Univ of Chicago Children's Hosp Chicago Illinois
United States Children's Med Ctr of Dallas Dallas Texas
United States Children's Hosp of Michigan Detroit Michigan
United States Duke Univ Med Ctr Durham North Carolina
United States North Broward Hosp District Fort Lauderdale Florida
United States Univ of Florida Gainesville Gainesville Florida
United States North Shore Univ Hosp Great Neck New York
United States Long Beach Memorial (Pediatric) Long Beach California
United States Harbor - UCLA Med Ctr / UCLA School of Medicine Los Angeles California
United States Los Angeles County - USC Med Ctr Los Angeles California
United States Saint Jude Children's Research Hosp of Memphis Memphis Tennessee
United States Univ of Miami (Pediatric) Miami Florida
United States Univ of South Alabama Mobile Alabama
United States Schneider Children's Hosp New Hyde Park New York
United States Earl K Long Early Intervention Clinic New Orleans Louisiana
United States Tulane Univ / Charity Hosp of New Orleans New Orleans Louisiana
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Columbia Presbyterian Med Ctr New York New York
United States Harlem Hosp Ctr New York New York
United States Incarnation Children's Ctr / Columbia Presbyterian Med Ctr New York New York
United States Metropolitan Hosp Ctr New York New York
United States Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl Newark New Jersey
United States Univ of Medicine & Dentistry of New Jersey / Univ Hosp Newark New Jersey
United States Children's Hosp of the King's Daughters Norfolk Virginia
United States Children's Hosp of Oakland Oakland California
United States Med College of Virginia Richmond Virginia
United States UCSF / Moffitt Hosp - Pediatric San Francisco California
United States Baystate Med Ctr of Springfield Springfield Massachusetts
United States State Univ of New York at Stony Brook Stony Brook New York
United States SUNY Health Sciences Ctr at Syracuse / Pediatrics Syracuse New York
United States Howard Univ Hosp Washington District of Columbia
United States Univ of Massachusetts Med School Worcester Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

King JR, Nachman S, Yogev R, Hodge J, Aldrovandi G, Hughes MD, Chen J, Wiznia A, Damle B, Acosta EP. Efficacy, tolerability and pharmacokinetics of two nelfinavir-based regimens in human immunodeficiency virus-infected children and adolescents: pediatric — View Citation

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