Effects of Changing HIV Therapy at Lower Versus Higher Viral Loads
A Phase II, Randomized, Controlled, Pilot Study of Antiretroviral Switch at Lower Versus Higher HIV-1 RNA Levels in Subjects Experiencing Virologic Relapse on a Current HAART Regimen
4 other identifiers
interventional
60
1 country
23
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2002
CompletedFirst Posted
Study publicly available on registry
May 13, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedJuly 29, 2013
July 1, 2013
May 10, 2002
July 26, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-infected.
- Have a CD4 cell count of 200 cells/mm3 or more within 45 days prior to entry.
- Are currently receiving the same HAART regimen for at least 4 months.
- Had a documented viral load of less than 500 copies/ml at any time prior to screening on the current stable antiretroviral regimen.
- Have a detectable plasma viral load on current stable anti-HIV regimen, as defined in the protocol, within 52 weeks prior to screening.
- Are willing to remain on their current regimen until their scheduled switch.
- Have a negative pregnancy test within 48 hours prior to entry.
- Are at least 13 years old.
- Agree not to participate in the conception process (active attempts to become pregnant or to make someone pregnant) while on study and for 60 days after going off study.
- Agree to use 2 acceptable forms of contraception while on study and for 60 days after going off study.
You may not qualify if:
- Patients may not be eligible for this study if they:
- Do not adhere with current antiretroviral therapy.
- Have an infection or cancer that requires treatment within 45 days prior to entry.
- Are pregnant or breast-feeding.
- Have used any experimental agents, systemic corticosteroids, or drugs that interfere with the immune system within 45 days prior to entry.
- Have received any HIV vaccine within 90 days prior to entry.
- Use drugs or alcohol that, in the opinion of the investigator, would interfere with the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Willow Clinic
Menlo Park, California, 94025, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 94305-5107, United States
Stanford Univ Med Ctr
Stanford, California, 94305-5107, United States
Harbor General/UCLA
Torrance, California, 90502-2052, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Northwestern Univ
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Harvard (Masschusetts General Hosp)
Boston, Massachusetts, 02114, United States
Brigham and Womens Hosp
Boston, Massachusetts, 02215, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Univ of North Carolina
Chapel Hill, North Carolina, 27599-7215, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906, United States
Comprehensive Care Clinic / Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203, United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390, United States
Univ of Texas Galveston
Galveston, Texas, 775550435, United States
Univ of Washington
Seattle, Washington, 98104, United States
Related Publications (1)
Riddler SA, Jiang H, Tenorio A, Huang H, Kuritzkes DR, Acosta EP, Landay A, Bastow B, Haas DW, Tashima KT, Jain MK, Deeks SG, Bartlett JA. A randomized study of antiviral medication switch at lower- versus higher-switch thresholds: AIDS Clinical Trials Group Study A5115. Antivir Ther. 2007;12(4):531-41. doi: 10.1177/135965350701200415.
PMID: 17668562DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sharon Riddler
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2002
First Posted
May 13, 2002
Study Completion
September 1, 2005
Last Updated
July 29, 2013
Record last verified: 2013-07