Clinical trial NCT01694017: Economic, Clinical and Quality of Life Assessment in Patients on Antiretroviral Therapy
Official title: Economic Evaluation of Treatment of HIV With Zidovudine/Stavudine and Tenofovir Regimen: A Cost Effectiveness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: HIV,treatment,cost effectiveness,drug toxicity,QOL,costs
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Christian Medical College, Vellore, India
First posted: 2012-09-26
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare clinical, economical and quality of life (QOL) outcomes in patients living with HIV on zidovudine/stavudine regimen and tenofovir regimen. This study will be an unblinded randomized trial. The first step will be empirical data collection for one year for calculating the incremental cost effectiveness ratio (ICER). The second step will be to perform a simulation model for calculating long term ICER.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Viral suppression
timeFrame: End of follow-up : end of 12th Month
measure: Change in CD4 levels
timeFrame: End of Months 6 and 12
measure: Drug related toxicity
timeFrame: Months : 1,2,3,4,5,6,7,8,9,10,11,12
measure: opportunistic infections
timeFrame: Months: 1,2,3,4,5,6,7,8,9,10,11,12
measure: Direct costs
timeFrame: Months: 1,2,3,4,5,6,7,8,9,10,11,12
measure: Quality of life
timeFrame: Month 1 and end of months 4,8 and 12
Secondary outcomes:
Other outcomes:
Locations:
city: Vellore
country: India
facility: Christian Medical College
state: Tamilnadu
Study officials:
affiliation: Tufts University
name: Christine C Wanke, MD
role: STUDY_CHAIR
affiliation: Tufts University
name: Sowmyanarayanan V Thuppal, MD
role: PRINCIPAL_INVESTIGATOR
References: