- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00005017
Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment
A Phase IV, Open-Label, Randomized Study to Compare the Efficacy and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) for 96 Weeks in the Treatment of HIV-1 Infected Subjects Who Are Antiretroviral Therapy Naive
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Patients are randomized to initiate antiretroviral therapy in 1 of 3 treatment groups. Within each group they are stratified based on HIV-1 plasma RNA levels.
Group 1: Patients receive 3TC/ABC/d4T; Group 2: Patients receive 3TC/ABC/EFV; and Group 3: Patients receive 3TC/ABC/APV/RTV.
Treatment continues for 96 weeks. Blood samples are collected to measure plasma HIV RNA and CD4 counts and patients are assessed regularly. In the event of incomplete viral suppression or virologic failure, patients will be switched to secondary therapy.
Studietype
Registrering
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
North Carolina
-
Research Triangle Park, North Carolina, Forente stater, 27709
- Jaime Hernandez
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria
Patients may be eligible for this trial if they:
- Are HIV-positive.
- Are at least 18 years old.
- Have a viral load of at least 5,000 copies/ml.
- Have a CD4 count of at least 50 cells/mm3.
- Agree to practice effective methods of birth control while on the study, if a woman.
Patients are not eligible for this trial if they:
Are pregnant or breast-feeding. Have ever taken anti-HIV drugs. (Less than 2 weeks of prior anti-HIV treatment is allowed.) Have a history of AIDS-defining opportunistic illness (except for Kaposi's sarcoma involving skin) within 45 days of the screening visit. Treatment for the illness must have been completed at least 30 days prior to screening.
Are enrolled in another study where the medication may interfere with the control of viral load in this study.
Have a serious medical condition such as diabetes or heart problems that would make it unsafe to be on this study.
Have a history of a severe nerve disease of the type that may cause muscle weakness.
Have had pancreatitis (inflamed pancreas) or hepatitis within 6 months of starting the study.
Have had radiation treatment or chemotherapy within 4 weeks prior to study entry, or think those treatments may be needed during the study period. Local treatment for Kaposi's sarcoma is allowed.
Have used certain medications, including vaccines, that interfere with the immune system within 4 weeks prior to study entry.
Have taken an HIV vaccine within 3 months prior to entry. Are taking St. John's wort. Have a history of being allergic to any of the study drugs.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- HIV-infeksjoner
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Revers transkriptasehemmere
- Nukleinsyresyntesehemmere
- Enzymhemmere
- Anti-HIV-midler
- Antiretrovirale midler
- Antimetabolitter
- Proteasehemmere
- Antibakterielle midler
- Cytokrom P-450 CYP3A-hemmere
- Cytokrom P-450 enzymhemmere
- Cytokrom P-450 enzymindusere
- Cytokrom P-450 CYP3A indusere
- HIV-proteasehemmere
- Virale proteasehemmere
- Antituberkulære midler
- Antibiotika, Antituberkulær
- Cytokrom P-450 CYP2B6 indusere
- Cytokrom P-450 CYP2C9-hemmere
- Cytokrom P-450 CYP2C19-hemmere
- Ritonavir
- Lamivudin
- Stavudine
- Efavirenz
- Abacavir
- Amprenavir
Andre studie-ID-numre
- 264N
- ESS40001
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