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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Tufts University
Sponsor:
Collaborator:
Christian Medical College, Vellore, India
Information provided by (Responsible Party):
Christine A. Wanke, Tufts University
ClinicalTrials.gov Identifier:
NCT01694017
First received: September 18, 2012
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
HIV
Drug: Tenofovir
Drug: Zidovudine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Economic Evaluation of Treatment of HIV With Zidovudine/Stavudine and Tenofovir Regimen: A Cost Effectiveness Study

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Viral suppression [ Time Frame: End of follow-up : end of 12th Month ] [ Designated as safety issue: No ]
  • Change in CD4 levels [ Time Frame: End of Months 6 and 12 ] [ Designated as safety issue: No ]
  • Drug related toxicity [ Time Frame: Months : 1,2,3,4,5,6,7,8,9,10,11,12 ] [ Designated as safety issue: Yes ]
  • opportunistic infections [ Time Frame: Months: 1,2,3,4,5,6,7,8,9,10,11,12 ] [ Designated as safety issue: Yes ]
  • Direct costs [ Time Frame: Months: 1,2,3,4,5,6,7,8,9,10,11,12 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Month 1 and end of months 4,8 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: November 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zidovudine
zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
Drug: Zidovudine
zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
Other Names:
  • Lazid-N
  • Duovir-N
  • Zidolam-N
Active Comparator: Tenofovir
tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
Drug: Tenofovir
tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
Other Names:
  • Atripla
  • Vonavir

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694017

Contacts
Contact: Wanke C Wanke, MD 617-636-3811 christine.wanke@tufts.edu

Locations
India
Christian Medical College Recruiting
Vellore, Tamilnadu, India, 632004
Contact: Sowmyanarayanan V Thuppal, MD    91-9498092370    sowmyanarayanan.thuppal@tufts.edu   
Principal Investigator: Sowmyanarayanan V Thuppal, MD         
Sponsors and Collaborators
Tufts University
Christian Medical College, Vellore, India
Investigators
Study Chair: Christine C Wanke, MD Tufts University
Principal Investigator: Sowmyanarayanan V Thuppal, MD Tufts University
  More Information

No publications provided

Responsible Party: Christine A. Wanke, Professor of Medicine and Public Health and Community Medicine, Tufts University
ClinicalTrials.gov Identifier: NCT01694017     History of Changes
Other Study ID Numbers: 10465
Study First Received: September 18, 2012
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board
India: Institutional Review Board

Keywords provided by Tufts University:
HIV,treatment,cost effectiveness,drug toxicity,QOL,costs

Additional relevant MeSH terms:
Zidovudine
Tenofovir
Tenofovir disoproxil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 23, 2014