Economic, Clinical and Quality of Life Assessment in Patients on Antiretroviral Therapy
NCT ID: NCT01694017
Last Updated: 2014-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
68 participants
INTERVENTIONAL
2012-11-30
2014-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Zidovudine
zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
Zidovudine
zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
Tenofovir
tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
Tenofovir
tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
Interventions
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Tenofovir
tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
Zidovudine
zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Christian Medical College, Vellore, India
OTHER
Tufts University
OTHER
Responsible Party
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Christine A. Wanke
Professor of Medicine and Public Health and Community Medicine
Principal Investigators
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Christine C Wanke, MD
Role: STUDY_CHAIR
Tufts University
Sowmyanarayanan V Thuppal, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts University
Locations
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Christian Medical College
Vellore, Tamil Nadu, India
Countries
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Other Identifiers
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10465
Identifier Type: -
Identifier Source: org_study_id