- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00158470
Feasibility Study of a Once Daily Antiretroviral Regimen in Vietnam (ANRS 1210 VIETAR)
Feasibility Study of a Once Daily Antiretroviral Regimen for HIV-Infected Patients With CD4 Below 200/mm3, in Hô Chi Minh City, Vietnam
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Despite a high number of infected subjects (estimated of 250,000 at the end of 2004) and a rapid spread of HIV infection in Vietnam, the use of anti-retroviral therapy remains limited. However, access to care and treatment will be expanded in Vietnam in the next few years with the support of national and international organisations. ANRS 1210 study is the first pilot program using highly active antiretroviral therapy (HAART) to evaluate the efficacy and the tolerance of an antiretroviral therapy delivered to adults in an external system of medical care, in Ho Chi Minh City. This feasibility study has also the objective to evaluate the cause of treatment failures and to assess social and behavioural conditions of patients at different stages during the treatment.
The present study is an open trial with direct individual benefit. The chosen treatment is a once-daily administration of 3TC, ddI and Efavirenz delivered to HIV infected adults with a CD4 count below 200/mm3. The duration of the study is eighteen months with a main evaluation at six months. One hundred patients will be selected in outpatient consultation of Binh Trieu hospital and Tropical Diseases Hospital of Ho Chi Minh City. The main criteria of evaluation will be the immunological response at 6 months, opportunistic infection events and the proportion of patients undergoing a regular monitoring at 6 months. Viral response will be also appreciated but, for technical question, will not be a main criteria of the study.
Patients are also administered a questionnaire by a trained independent interviewer about adherence to treatment, mental well-being, housing and nutrition, drug and sexual behaviour, social support and disclosure in order to study the associations between sociobehavioural dimensions, adherence and viral load at two successive follow-up visits.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
-
Ho Chi Minh City, Vietnam
- Binh Trieu Hospital
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Ho Chi Minh City, Vietnam
- Tropical Diseases Hospital
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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:
- Man or woman over 18 years old
- HIV infected
- Written informed consent signed
- CD4 count lower than 200/mm3
- No previous antiretroviral treatment
- Weight over 45 kilos and/or body mass index over 16
- Karnofsky Index over or equal to 70 percent
Exclusion Criteria:
- Pregnant woman or woman without effective contraception
- Opportunistic infection compromising the realisation of the treatment
- Tumoral pathology
- Progressive psychiatric affection
- Previous history of peripheral neuropathy or pancreatitis
- Hemoglobin above 90 g/l
- PMN neutrophil above 1.0G/l
- Platelets above 50G/l
- Liver enzymes over 5 times the normal values
- Lipase and/or amylase over 2 times the normal values
- Prothrombin rate above 50 percent
- Plasmatic creatinine over 200 micromoles/l
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
CD4 lymphocyte count after HAART
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Evaluation of treatment failures causes
Tidsramme: 12 months
|
12 months
|
Assessment of patients social and behavioral conditions at different stages during the treatment
Tidsramme: 12 months
|
12 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Jean Yves Follezou, Pr, CHU Pitié-Salpêtrière, Paris, France
- Hovedetterforsker: Huu Chi Nguyen, Dr, Tropical Diseases Hospital - Ho Chi Minh City - Vietnam
Studierekorddatoer
Studer hoveddatoer
Studiestart
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 (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
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
- Cytokrom P-450 enzymhemmere
- Cytokrom P-450 enzymindusere
- Cytokrom P-450 CYP3A indusere
- Cytokrom P-450 CYP2B6 indusere
- Cytokrom P-450 CYP2C9-hemmere
- Cytokrom P-450 CYP2C19-hemmere
- Lamivudin
- Didanosin
- Efavirenz
Andre studie-ID-numre
- ANRS 1210 VIETAR
- VIETAR
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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