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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts University
• Collaborator: Christian Medical College, Vellore, India
• Treatments: Tenofovir; Zidovudine

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