Salvage Treatment, Resistance Testing, and Withdrawal of Anti-HIV Drugs for HIV Patients Failing Current Anti-HIV Treatment
Phase III Evaluation of the Role of Temporary Cessation of Antiretroviral Treatment and Resistance Testing-Based Selection of Antiretroviral Drugs in the Virologic Response to Salvage Therapy for Heavily Treatment-Experienced HIV-Infected Individuals Failing Current Antiretroviral Therapy
4 other identifiers
interventional
N/A
2 countries
30
Brief Summary
The purpose of this study is to test another way to control the amount of HIV in the blood (viral load). Studies show that stopping all anti-HIV drugs for a time before switching to new anti-HIV drugs may improve the response in some individuals who are failing treatment. Other studies suggest a benefit if drug-resistance tests are used in selecting a new anti-HIV drug treatment. This study tests the effect of stopping anti-HIV drugs for a time before switching to anti-HIV drugs selected using drug-resistance test results.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMay 18, 2015
May 1, 2004
February 10, 2001
May 15, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-infected.
- Are likely to have drug-resistant HIV from having taken all types of anti-HIV drugs (protease inhibitors \[PIs\], nucleoside reverse transcriptase inhibitors \[NRTIs\], and nonnucleoside reverse transcriptase inhibitors \[NNRTIs\]), and having failed treatment prior to the current treatment for reasons other than toxicity.
- Are currently receiving anti-HIV treatment with at least 3 drugs. Low doses of ritonavir (100 to 200 mg twice daily) taken with 1 other PI is counted as a single PI.
- Are currently failing treatment due to a high viral load (amount of HIV in the blood).
- Have had a new anti-HIV drug combination selected.
- Are at least 18 years old.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have stopped treatment for more than 4 weeks in the past 6 months.
- Are pregnant or breast-feeding.
- Have cancer that requires systemic treatment or radiation.
- Have received the following medications affecting the immune system within 14 days before entry: erythropoietin; Granulocyte Colony Stimulating Factor (G-CSF), including Granulocyte Macrophage Colony Stimulating Factors (GM-CSF); interleukins; or therapeutic HIV vaccines.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Willow Clinic
Menlo Park, California, 94025, United States
Univ of California, San Diego
San Diego, California, 92103, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, 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
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Wishard Hosp
Indianapolis, Indiana, 46202, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, 10011, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Community Health Network Inc
Rochester, New York, 14642, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203, United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235, United States
Univ of Puerto Rico
San Juan, 009365067, Puerto Rico
Related Publications (7)
Montaner JS, Harrigan PR, Jahnke N, Raboud J, Castillo E, Hogg RS, Yip B, Harris M, Montessori V, O'Shaughnessy MV. Multiple drug rescue therapy for HIV-infected individuals with prior virologic failure to multiple regimens. AIDS. 2001 Jan 5;15(1):61-9. doi: 10.1097/00002030-200101050-00010.
PMID: 11192869BACKGROUNDLorenzi P, Opravil M, Hirschel B, Chave JP, Furrer HJ, Sax H, Perneger TV, Perrin L, Kaiser L, Yerly S. Impact of drug resistance mutations on virologic response to salvage therapy. Swiss HIV Cohort Study. AIDS. 1999 Feb 4;13(2):F17-21. doi: 10.1097/00002030-199902040-00001.
PMID: 10202819BACKGROUNDHance AJ, Lemiale V, Izopet J, Lecossier D, Joly V, Massip P, Mammano F, Descamps D, Brun-Vezinet F, Clavel F. Changes in human immunodeficiency virus type 1 populations after treatment interruption in patients failing antiretroviral therapy. J Virol. 2001 Jul;75(14):6410-7. doi: 10.1128/JVI.75.14.6410-6417.2001.
PMID: 11413308BACKGROUNDClevenbergh P, Durant J, Halfon P, del Giudice P, Mondain V, Montagne N, Schapiro JM, Boucher CA, Dellamonica P. Persisting long-term benefit of genotype-guided treatment for HIV-infected patients failing HAART. The Viradapt Study: week 48 follow-up. Antivir Ther. 2000 Mar;5(1):65-70.
PMID: 10846595BACKGROUNDDelaugerre C, Valantin MA, Mouroux M, Bonmarchand M, Carcelain G, Duvivier C, Tubiana R, Simon A, Bricaire F, Agut H, Autran B, Katlama C, Calvez V. Re-occurrence of HIV-1 drug mutations after treatment re-initiation following interruption in patients with multiple treatment failure. AIDS. 2001 Nov 9;15(16):2189-91. doi: 10.1097/00002030-200111090-00016.
PMID: 11684940BACKGROUNDBenson CA, Vaida F, Havlir DV, Downey GF, Lederman MM, Gulick RM, Glesby MJ, Wantman M, Bixby CJ, Rinehart AR, Snyder S, Wang R, Patel S, Mellors JW; ACTG A5086 Study Team. A randomized trial of treatment interruption before optimized antiretroviral therapy for persons with drug-resistant HIV: 48-week virologic results of ACTG A5086. J Infect Dis. 2006 Nov 1;194(9):1309-18. doi: 10.1086/508289. Epub 2006 Sep 22.
PMID: 17041858RESULTWang R, Bosch RJ, Benson CA, Lederman MM. Drug-resistant virus has reduced ability to induce immune activation. J Acquir Immune Defic Syndr. 2012 Dec 1;61(4):e60-3. doi: 10.1097/QAI.0b013e31827171d7. No abstract available.
PMID: 23138731DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Constance A Benson, MD
University of Colorado, Denver
- STUDY CHAIR
John Mellors, MD
University of Pittsburgh
- STUDY CHAIR
Diane Havlir, MD
University of California, San Francisco