- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00004855
Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
A Randomized, Open-Label, Pilot Treatment Trial Evaluating Cellular Dynamics and Immune Restoration in Treatment-Naive HIV-Infected Subjects Receiving Either the Protease Inhibitor LPV/r or the Nucleoside Analogue Reverse Transcriptase Inhibitors d4T/3TC/Abacavir With the Non-Nucleoside Reverse Transcriptase Inhibitor Nevirapine
This study will compare an anti-HIV drug combination of protease inhibitor plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) to one that includes three nucleoside reverse transcriptase inhibitors (NRTIs) plus an NNRTI. NNRTIs, NRTIs, and protease inhibitors are all types of anti-HIV drugs that block the virus in some way.
This study will try to find out if a treatment regimen containing a protease inhibitor plus an NNRTI has a different effect on the rise of CD4 cells compared to a treatment made up of three NRTIs plus an NNRTI. CD4 cells are cells of the immune system that fight infection. This study will also try to see if the combination of drugs used in this study is safe to use in HIV-positive patients.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study is designed to further define the dynamics and the mechanisms of the CD4 cell rise seen following administration of potent antiretroviral therapy. It will ascertain if treatment regimens containing nucleoside reverse transcriptase inhibitors (NRTIs) with a nonnucleoside reverse transcriptase inhibitor (NNRTI) have different effects on CD4 dynamics than regimens composed of a protease inhibitor with an NNRTI.
Patients are randomized to one of the two treatment arms listed below. They are stratified based on CD4 count and whether they choose to participate in substudy A5036s.
Arm A (protease inhibitor plus NNRTI regimen): At Day 0 (entry), patients begin taking LPV/RTV. At Day 3, patients add NVP, once daily for 2 weeks and then twice daily for the remainder of the study.
Arm B (triple reverse transcriptase inhibitors plus NNRTI regimen): At Day 0 (entry), patients begin taking 3TC plus d4T plus ABC. At Day 3, patients add NVP, once daily for 2 weeks and then twice daily for the remainder of the study.
HIV RNA analysis is performed at Weeks 4 and 5. If the mean is at least 1.0 log10 lower than the baseline HIV RNA, the patient may continue on study treatment. If the mean is not at least 1.0 log10 lower, however, patients are discontinued from the study by no later than Week 8. After 8 weeks of treatment, patients may change antiretroviral medications with permission of the protocol chair or vice chairs. Regular clinical evaluations are conducted. Blood is drawn to determine HIV RNA quantification, absolute CD4 and CD8 counts, immunological evaluations, telomere assays, and part is stored for future testing. Skin testing and return visits for delayed-type hypersensitivity to standard recall antigens are done on three occasions. Patients remain on the study for 48 weeks. Substudy A5036s evaluates viral dynamics during study treatment. Serial plasma samples are collected during the first 24 hours of treatment and at Day 3 and Week 4. Plasma HIV measurements are performed to differentiate between infectious and non-infectious particle production.
Tipo di studio
Iscrizione
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 900331079
- Univ of Southern California / LA County USC Med Ctr
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Colorado
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Denver, Colorado, Stati Uniti, 80262
- Univ of Colorado Health Sciences Ctr
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Denver, Colorado, Stati Uniti, 80262
- Denver Dept of Health and Hosps
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96816
- Univ of Hawaii
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Northwestern Univ Med School
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Chicago, Illinois, Stati Uniti, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Chicago, Illinois, Stati Uniti, 60612
- Cook County Hosp
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Indiana
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Indianapolis, Indiana, Stati Uniti, 462025250
- Indiana Univ Hosp
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Indianapolis, Indiana, Stati Uniti, 46202
- Methodist Hosp of Indiana / Life Care Clinic
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Indianapolis, Indiana, Stati Uniti, 46202
- Division of Inf Diseases/ Indiana Univ Hosp
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Maryland
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Baltimore, Maryland, Stati Uniti, 21287
- Johns Hopkins Hosp
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Beth Israel Deaconess - West Campus
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New York
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New York, New York, Stati Uniti, 10003
- Beth Israel Med Ctr
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New York, New York, Stati Uniti, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, Stati Uniti, 10029
- Mount Sinai Med Ctr
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Rochester, New York, Stati Uniti, 14642
- Univ of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 275997215
- Univ of North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke Univ Med Ctr
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Ohio
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Cincinnati, Ohio, Stati Uniti, 452670405
- Univ of Cincinnati
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Cleveland, Ohio, Stati Uniti, 44106
- Case Western Reserve Univ
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Cleveland, Ohio, Stati Uniti, 441091998
- MetroHealth Med Ctr
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02906
- Miriam Hosp / Brown Univ
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Texas
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Galveston, Texas, Stati Uniti, 775550435
- Univ of Texas Galveston
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria
Patients may be eligible for this study if they:
- Are 18 years of age or older.
- Are HIV-positive.
- Have a CD4 count of 500 cells/mm3 or less.
- Have a viral load greater than 5,000 and less than 100,000 copies/ml.
- Are willing to use barrier methods of birth control (such as condoms) during the study and for 12 weeks after stopping treatment.
- Will most likely respond well to nevirapine. This is determined by the results of a test.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have ever taken any anti-HIV drugs. (Seven days or less of treatment will be allowed if it was received more than 30 days before study entry.)
- Have pancreatitis (an inflamed pancreas) or hepatitis within 2 weeks of study entry.
- Are pregnant or breast-feeding.
- Actively abuse drugs or alcohol which their doctor feels would interfere with the ability to fulfill study requirements.
- Have taken any medications within 14 days of study entry that would interfere with the study drugs.
- Are receiving or need to receive chemotherapy.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
Collaboratori e investigatori
Investigatori
- Cattedra di studio: Alan Landay
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie del sistema immunitario
- Infezioni da HIV
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti antivirali
- Inibitori della trascrittasi inversa
- Inibitori della sintesi degli acidi nucleici
- Inibitori enzimatici
- Agenti anti-HIV
- Agenti antiretrovirali
- Antimetaboliti
- Inibitori della proteasi
- Inibitori del citocromo P-450 CYP3A
- Inibitori dell'enzima del citocromo P-450
- Induttori enzimatici del citocromo P-450
- Induttori del citocromo P-450 CYP3A
- Inibitori della proteasi dell'HIV
- Inibitori virali della proteasi
- Nevirapina
- Ritonavir
- Lopinavir
- Lamivudina
- Stavudina
- Abacavir
Altri numeri di identificazione dello studio
- A5014
- 10866 (Identificatore di registro: DAIDS ES)
- ACTG A5014
- AACTG A5014
- Substudy ACTG AA5036s
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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