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A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy

NCT00001948 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2008-03-04

No results posted yet for this study

Summary

This study will examine and compare the health-related quality of life and degree of symptom discomfort in two groups of patients receiving intensive drug therapy for HIV infection. One group will receive continuous treatment over the entire 88-week study period; the other will have interruptions in therapy over the same time period.

Patients enrolled in the National Institute of Allergy and Infectious Disease's trial, "Immunologic and Virologic Studies of Intermittent versus Continuous HAART \[highly active antiretroviral therapy\] in the Treatment of HIV Disease," may participate in this study. At periodic intervals for a total of 7 times during the 88-week trial, this companion study will require participants in both the interrupted and the continuous therapy groups to complete the following two questionnaires:

1. MOS-HIV Health Survey - The patient provides a self-assessment of his or her physical and emotional well being. Survey questions are related to the ability to perform work and daily living activities, mood and state of mind, limitations on social activities, ability to concentrate, energy level, pain level, general quality of life, etc.
2. Symptom Distress Scale - The patient rates the degree of symptom distress by ranking from 1 to 5 his or her agreement with statements about various physical and emotional factors, including appetite, nausea, breathing, cough, pain, insomnia, fatigue, bowel problems, concentration, appearance, and outlook.

Understanding the impact of HIV treatments on health-related quality of life and symptom distress may provide information helpful in evaluating new treatment approaches.

Conditions

  • HIV Infection

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-12-31
Completion
2002-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00001948 on ClinicalTrials.gov