HIV Clinical Trial - Economic, Clinical & Quality of Life Assessment in

Status Completed

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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01694017
Study type	Interventional
Source	Tufts University
Contact
Status	Completed
Phase	Phase 4
Start date	November 2012
Completion date	August 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06162897` - Case Management Dyad	N/A
Completed	`NCT03999411` - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients	Phase 4
Completed	`NCT02528773` - Efficacy of ART to Interrupt HIV Transmission Networks
Active, not recruiting	`NCT05454839` - Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Recruiting	`NCT05322629` - Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women	N/A
Completed	`NCT02579135` - Reducing HIV Risk Among Adolescents: Evaluating Project HEART	N/A
Active, not recruiting	`NCT01790373` - Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence	N/A
Not yet recruiting	`NCT06044792` - The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
Completed	`NCT04039217` - Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM	Phase 4
Active, not recruiting	`NCT04519970` - Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)	N/A
Completed	`NCT04124536` - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women	N/A
Recruiting	`NCT05599581` - Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health	N/A
Active, not recruiting	`NCT04588883` - Strengthening Families Living With HIV in Kenya	N/A
Completed	`NCT02758093` - Speed of Processing Training in Adults With HIV	N/A
Completed	`NCT02500446` - Dolutegravir Impact on Residual Replication	Phase 4
Completed	`NCT03805451` - Life Steps for PrEP for Youth	N/A
Active, not recruiting	`NCT03902431` - Translating the ABCS Into HIV Care	N/A
Completed	`NCT00729391` - Women-Focused HIV Prevention in the Western Cape	Phase 2/Phase 3
Recruiting	`NCT05736588` - Elimisha HPV (Human Papillomavirus)	N/A
Recruiting	`NCT03589040` - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms