- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00000913
A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children
A Randomized Trial of Two Saquinavir-Containing Combination Treatment Regimens in Children With HIV Infection
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.]
Studietype
Registrering
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35233
- Univ of Alabama at Birmingham - Pediatric
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Birmingham, Alabama, Forente stater, 352330011
- Univ of Alabama at Birmingham / Childrens Hosp of AL
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California
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Long Beach, California, Forente stater, 90801
- Long Beach Memorial (Pediatric)
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Los Angeles, California, Forente stater, 90033
- Los Angeles County - USC Med Ctr
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Oakland, California, Forente stater, 946091809
- Children's Hosp of Oakland
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San Francisco, California, Forente stater, 941430105
- UCSF / Moffitt Hosp - Pediatric
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Connecticut
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New Haven, Connecticut, Forente stater, 06504
- Yale Univ Med School
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District of Columbia
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Washington, District of Columbia, Forente stater, 20060
- Howard Univ Hosp
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Florida
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Miami, Florida, Forente stater, 33161
- Univ of Miami (Pediatric)
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Riviera Beach, Florida, Forente stater, 33404
- Palm Beach County Health Dept
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Georgia
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Atlanta, Georgia, Forente stater, 30306
- Emory Univ Hosp / Pediatrics
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Cook County Hosp
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Chicago, Illinois, Forente stater, 606143394
- Chicago Children's Memorial Hosp
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Chicago, Illinois, Forente stater, 60612
- Univ of Illinois College of Medicine / Pediatrics
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Louisiana
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New Orleans, Louisiana, Forente stater, 701122699
- Tulane Univ / Charity Hosp of New Orleans
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- Univ of Maryland at Baltimore / Univ Med Ctr
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Massachusetts
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Boston, Massachusetts, Forente stater, 021155724
- Children's Hosp of Boston
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Springfield, Massachusetts, Forente stater, 01199
- Baystate Med Ctr of Springfield
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Mississippi
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Jackson, Mississippi, Forente stater, 39213
- Univ of Mississippi Med Ctr
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New Jersey
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Newark, New Jersey, Forente stater, 071032714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
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New York
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Albany, New York, Forente stater, 12208
- Children's Hosp at Albany Med Ctr
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Bronx, New York, Forente stater, 10461
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
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Bronx, New York, Forente stater, 10457
- Bronx Lebanon Hosp Ctr
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Great Neck, New York, Forente stater, 11021
- North Shore Univ Hosp
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New York, New York, Forente stater, 10021
- Cornell Univ Med College
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New York, New York, Forente stater, 10032
- Columbia Presbyterian Med Ctr
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New York, New York, Forente stater, 10032
- Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
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New York, New York, Forente stater, 10037
- Harlem Hosp Ctr
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Stony Brook, New York, Forente stater, 117948111
- State Univ of New York at Stony Brook
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 191341095
- Saint Christopher's Hosp for Children
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South Carolina
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Charleston, South Carolina, Forente stater, 294253312
- Med Univ of South Carolina
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Virginia
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Richmond, Virginia, Forente stater, 23219
- Med College of Virginia
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Washington
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Seattle, Washington, Forente stater, 981050371
- Children's Hospital & Medical Center / Seattle ACTU
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Bayamon, Puerto Rico, 00956
- Ramon Ruiz Arnau Univ Hosp / Pediatrics
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San Juan, Puerto Rico, 009367344
- San Juan City Hosp
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San Juan, Puerto Rico, 009365067
- Univ of Puerto Rico / Univ Children's Hosp AIDS
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Courtney Fletcher
- Studiestol: Mark Kline
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Brundage RC, Kline MW, Lindsey J, Fenton T, Fletcher CV. Pharmacokinetics of saquinavir (SQV) with nelfinavir (NFV) or ritonavir (RTV) in HIV-infected children. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 728)
- Kline MW, Fletcher CV, Lindsey JC, Fenton T. A randomized trial of two saquinavir (SQV-SGC)-containing combination treatment regimens in HIV-infected children. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 [Poster 694]
- Kline MW, Fletcher CV, Lindsey JC, Fenton T. A randomized trial of combination therapy with saquinavir soft gelatin capsules (SQV) in HIV-infected children. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 683)
- Brundage RC, Kline MW, Lindsey JC, Fenton T, Fletcher CV. Pharmacokinetics (PK) of saquinavir (SQV) and nelfinavir (NFV) in a twice-daily (BID) regimen in HIV-infected children. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 [Poster 718]
Studierekorddatoer
Studer hoveddatoer
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Langsomme virussykdommer
- HIV-infeksjoner
- Infeksjoner
- Ervervet immunsviktsyndrom
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Anti-HIV-midler
- Antiretrovirale midler
- Proteasehemmere
- Cytokrom P-450 CYP3A-hemmere
- Cytokrom P-450 enzymhemmere
- HIV-proteasehemmere
- Virale proteasehemmere
- Ritonavir
- Nelfinavir
- Saquinavir
Andre studie-ID-numre
- ACTG 397
- 11353 (Registeridentifikator: DAIDS ES)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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