Effects of Two Anti-HIV Drug Regimens on Quality of Life and Health Care Use Among SMART Study Participants

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Antiretroviral Regimens

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00385632

SMART

CPCRA 065A

10112 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to compare the effects of two different anti-HIV drug regimens on quality of life and health care utilization among SMART study participants.

Full description

Advances in antiretroviral therapy (ART) have dramatically reduced mortality and morbidity rates for HIV infected people. However, HIV infection is a costly disease to treat. With improvement in survival, quality of life and the long-term cost of HIV treatment have become increasingly important to the majority of individuals infected with HIV. Different HIV treatment regimens may lead to variations in quality of life and health care costs over the course of treatment. In the SMART study, participants were randomly assigned to one of two treatment groups:

• Group 1 participants followed a drug conservation (DC) regimen in which ART was stopped or deferred until CD4 cell count dropped below 250 cells/mm3, initiated until CD4 cell count was at least 350 cells/mm3, and then followed by episodic ART based on CD4 cell count.
• Group 2 participants followed a viral suppression (VS) regimen in which ART was continued to keep viral loads as low as possible, regardless of CD4 cell count.

The purpose of this study is to compare how the DC and VS regimens affect quality of life, symptom severity, health care utilization, and resulting costs among SMART study participants.

At baseline, participants will complete questionnaires regarding quality of life, symptoms, health care utilization, current insurance, and socioeconomic status. Body appearance and signs of HIV disease progression will also be assessed at this time. Follow-up evaluations on quality of life and symptoms will be repeated at Months 4, 8, and 12 and annually thereafter. Follow-up evaluations of all other baseline measures will occur once a year.

Enrollment: 1,224 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Coenrollment in the SMART study
• Parent or guardian willing to provide informed consent, if applicable

Trial design

1,224 participants in 2 patient groups

1

Description:

Participants following a drug conservation (DC) regimen in which ART was stopped or deferred until CD4 cell count dropped below 250 cells/mm3, initiated until CD4 cell count was at least 350 cells/mm3, and then followed by episodic ART based on CD4 cell count

Treatment:

Drug: Antiretroviral Regimens

2

Description:

Participants following a viral suppression (VS) regimen in which ART was continued to keep viral loads as low as possible, regardless of CD4 cell count

Treatment:

Drug: Antiretroviral Regimens