MedTrace Logo

Effects of Changing HIV Therapy at Lower Versus Higher Viral Loads

NCT00036465 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-07-29

No results posted yet for this study

Summary

This study will look at people who have been taking anti-HIV drugs but still have detectable levels of HIV. The purpose of the study is to find out what happens in those people who change anti-HIV drugs when their viral load reaches 200 copies compared to those who change anti-HIV drugs when their viral load reaches 10,000 copies. This study will also look at drug resistance (how well HIV responds to drugs), viral fitness (how well drug-resistant HIV copies itself), and immunologic reconstitution (how well the immune system recognizes various infections, including HIV).

Many patients experience virologic relapse (increase in viral load after sustained viral load suppression) within 1 to 2 years of taking anti-HIV drugs. The approach to treatment for patients who experience virologic relapse while on a highly active antiretroviral therapy (HAART) has not been defined. Current guidelines recommend switching to a new treatment regimen as soon as possible to prevent HIV from becoming even more resistant to anti-HIV drugs. However, there is evidence that patients can benefit from staying on the same HAART drugs, even after virologic relapse. This study wants to find what happens when drugs are changed immediately after virologic relapse (when the viral load is lower) compared to what happens if drugs are changed only after a delay (when the viral load is higher).

Conditions

  • HIV Infections

Interventions

BEHAVIORAL

Treatment regimen change

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Sharon Riddler

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2005-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00036465 on ClinicalTrials.gov