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

NCT01694017 | Completed Phase 4 DMC

• 1 other identifier: 10465
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV,treatment,cost effectiveness,drug toxicity,QOL,costs

Outcome Measures

Primary Outcomes (6)

• Viral suppression

  End of follow-up : end of 12th Month

• Change in CD4 levels

  End of Months 6 and 12

• Drug related toxicity

  Months : 1,2,3,4,5,6,7,8,9,10,11,12

• opportunistic infections

  Months: 1,2,3,4,5,6,7,8,9,10,11,12

• Direct costs

  Months: 1,2,3,4,5,6,7,8,9,10,11,12

• Quality of life

  Month 1 and end of months 4,8 and 12

Study Arms (2)

Zidovudine

ACTIVE COMPARATOR

zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year

Drug: Zidovudine

Tenofovir

ACTIVE COMPARATOR

tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year

Drug: Tenofovir

Interventions

Tenofovir DRUG

tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year

Also known as: Atripla, Vonavir

Tenofovir

Zidovudine DRUG

zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year

Also known as: Lazid-N, Duovir-N, Zidolam-N

Zidovudine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead
• Christian Medical College, Vellore, India: collaborator

Study Sites (1)

Christian Medical College

Vellore, Tamil Nadu, 632004, India

Location

MeSH Terms

Interventions

Tenofovir; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Zidovudine

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Drug Combinations; Pharmaceutical Preparations; Thymidine; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Christine C Wanke, MD

  Tufts University

  STUDY CHAIR

• Sowmyanarayanan V Thuppal, MD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Public Health and Community Medicine

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: September 26, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

IN (1)