Economic, Clinical and Quality of Life Assessment in Patients on Antiretroviral Therapy

HIV Clinical Trial

Official title:

Economic Evaluation of Treatment of HIV With Zidovudine/Stavudine and Tenofovir Regimen: A Cost Effectiveness Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694017
• Other study ID #: 10465
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2012
• Last updated: November 20, 2014
• Start date: November 2012
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• 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

Locations

Country	Name	City	State
India	Christian Medical College	Vellore	Tamilnadu

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	Christian Medical College, Vellore, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral suppression		End of follow-up : end of 12th Month	No
Primary	Change in CD4 levels		End of Months 6 and 12	No
Primary	Drug related toxicity		Months : 1,2,3,4,5,6,7,8,9,10,11,12	Yes
Primary	opportunistic infections		Months: 1,2,3,4,5,6,7,8,9,10,11,12	Yes
Primary	Direct costs		Months: 1,2,3,4,5,6,7,8,9,10,11,12	No
Primary	Quality of life		Month 1 and end of months 4,8 and 12	No