Economic, Clinical and Quality of Life Assessment in Patients on Antiretroviral Therapy
Economic Evaluation of Treatment of HIV With Zidovudine/Stavudine and Tenofovir Regimen: A Cost Effectiveness Study
Panoramica dello studio
Descrizione dettagliata
The drug regimen for treatment of HIV at the free ART centers in India includes stavudine/zidovudine and lamivudine with nevirapine. Approximately 20-30% of the patients on this regimen experience drug toxicity within the first six months of treatment.
The tenofovir based regimen is one of the least toxic regimens with less than 5% of patients experiencing toxicity. Tenofovir based regimen is not considered as the first choice for ART in the Indian governmental program, because it is more expensive than the other drug regimens, in spite of better clinical outcomes in resource limited settings. The cost of treatment with stavudine/zidovudine is presumed to be less expensive and is the preferred first line treatment, but we believe that although the direct cost to the government is less, patients on zidovudine/stavudine regimen have to spend more money for additional hospital visits and admissions, laboratory investigations and other medications due to ART induced toxicity.
There are no published data including economic, clinical and quality of life outcomes to compare the two regimens from India. Hence, this unblinded randomized pragmatic comparative effectiveness study will seek to identify the best treatment for HIV patients based on the incremental cost effectiveness ratio (ICER), quality of life (QOL) and clinical outcomes.
The clinical outcomes include viral suppression, change in the CD4 and proportion of patients with toxicity and opportunistic infections. Direct costs for the treatment will be calculated. The QOL scores will be estimated and compared between the regimens using questionnaires. QOL scores and direct cost will be used as utilities for calculating ICER.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
-
-
Tamilnadu
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Vellore, Tamilnadu, India, 632004
- Christian Medical College
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- All treatment naïve patients above 18 years confirmed with the diagnosis of HIV
- Eligible for initiation of cART based on the National Aids Control Organization of India
- Consenting for participation and follow-up for one year.
Exclusion Criteria:
- All patients requiring hospitalization at the time of initiation of treatment
- Patients with opportunistic infections including tuberculosis
- Patients with co-morbidities like diabetes or neurological impairments
- Pregnant and breast feeding women and children less than 18 years will be excluded
- All patients living outside the catchment area of CMC and not willing for regular follow-up will be excluded
- Patients with a creatinine clearance less than 50 mL/min will be excluded.
- Patients receiving other co-medications with possible interaction with tenofovir, like antifungal (voriconazole), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, and methylergonovine), benzodiazepines (midazolam, triazolam), calcium channel blocker (bepridil), GI motility agent (cisapride), neuroleptic (pimozide) and St.John's wort will be excluded.
- Patients with hemoglobin less than 8 gm/dl
- Patients started on tenofovir regimen by the treating physician at the time of enrollment will be excluded
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Zidovudine
zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
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zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
Altri nomi:
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|
Comparatore attivo: Tenofovir
tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
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tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Viral suppression
Lasso di tempo: End of follow-up : end of 12th Month
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End of follow-up : end of 12th Month
|
|
Change in CD4 levels
Lasso di tempo: End of Months 6 and 12
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End of Months 6 and 12
|
|
Drug related toxicity
Lasso di tempo: Months : 1,2,3,4,5,6,7,8,9,10,11,12
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Months : 1,2,3,4,5,6,7,8,9,10,11,12
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opportunistic infections
Lasso di tempo: Months: 1,2,3,4,5,6,7,8,9,10,11,12
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Months: 1,2,3,4,5,6,7,8,9,10,11,12
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Direct costs
Lasso di tempo: Months: 1,2,3,4,5,6,7,8,9,10,11,12
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Months: 1,2,3,4,5,6,7,8,9,10,11,12
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Quality of life
Lasso di tempo: Month 1 and end of months 4,8 and 12
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Month 1 and end of months 4,8 and 12
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Christine C Wanke, MD, Tufts University
- Investigatore principale: Sowmyanarayanan V Thuppal, MD, Tufts University
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
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 (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 10465 (Altro identificatore: Fred Hutch/University of Washington Cancer Consortium)
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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