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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
-
-
Tamilnadu
-
Vellore, Tamilnadu, Indië, 632004
- Christian Medical College
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Zidovudine
zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
|
zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
Andere namen:
|
|
Actieve vergelijker: Tenofovir
tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
|
tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Viral suppression
Tijdsspanne: End of follow-up : end of 12th Month
|
End of follow-up : end of 12th Month
|
|
Change in CD4 levels
Tijdsspanne: End of Months 6 and 12
|
End of Months 6 and 12
|
|
Drug related toxicity
Tijdsspanne: Months : 1,2,3,4,5,6,7,8,9,10,11,12
|
Months : 1,2,3,4,5,6,7,8,9,10,11,12
|
|
opportunistic infections
Tijdsspanne: Months: 1,2,3,4,5,6,7,8,9,10,11,12
|
Months: 1,2,3,4,5,6,7,8,9,10,11,12
|
|
Direct costs
Tijdsspanne: Months: 1,2,3,4,5,6,7,8,9,10,11,12
|
Months: 1,2,3,4,5,6,7,8,9,10,11,12
|
|
Quality of life
Tijdsspanne: Month 1 and end of months 4,8 and 12
|
Month 1 and end of months 4,8 and 12
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Christine C Wanke, MD, Tufts University
- Hoofdonderzoeker: Sowmyanarayanan V Thuppal, MD, Tufts University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 10465 (Andere identificatie: Fred Hutch/University of Washington Cancer Consortium)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .