Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients
A Restrictively Randomized, Open-Label, Controlled, Pilot Study of the Effect of a Thymidine Analogue Substitution or Change to a Nucleoside-Sparing Regimen on Peripheral Fat Wasting
3 other identifiers
interventional
150
1 country
25
Brief Summary
The goals of this study are to find out if fat wasting and weight loss in the arms and legs of HIV patients taking highly active antiretroviral therapy (HAART) are caused by nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and if wasting can be reversed if the NRTI is stopped and replaced with other anti-HIV drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started Mar 2002
Typical duration for not_applicable hiv-infections
25 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
December 20, 2001
CompletedFirst Posted
Study publicly available on registry
December 21, 2001
CompletedStudy Start
First participant enrolled
March 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedJuly 29, 2013
July 1, 2013
December 20, 2001
July 26, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- HIV infected
- Experiencing a loss of fat since starting anti-HIV therapy, especially in the arms and legs
- Receiving anti-HIV therapy of 3 or more drugs, including either stavudine or zidovudine, for 24 weeks or more prior to study screening
- Viral load less than 500 copies/ml at study screening and within 60 days prior to study entry
- CD4 count of 100 or more cells/mm3 obtained within 60 days prior to study entry
- Approved methods of contraception
- Written informed consent
You may not qualify if:
- Currently receiving abacavir sulfate or have received abacavir sulfate in the past AND any or all of the following: unable to tolerate lopinavir/ritonavir (LPV/r) or nevirapine (NVP); failed anti-HIV treatment containing LPV/r, any other 2 PIs, or any other NNRTI; taking lamivudine (3TC) or tenofovir disoproxil fumarate (TDF) for hepatitis B virus infection and need to remain on a 3TC- or TDF-containing regimen; or have a low chance of response to LPV/r plus NVP
- Cancer treatment 6 months prior to study entry
- Initiated oral drugs to lower blood sugar level 24 weeks prior to study entry. Patients who have taken oral drugs to lower their blood sugar levels for 24 weeks or more prior to study entry are eligible.
- Began therapy with male sex hormones 24 weeks prior to study entry. Patients who have had continuous, stable therapy with male sex hormones for 24 weeks or more prior to study entry are eligible.
- Certain medications within 14 days prior to study entry
- Serious illness within 14 days prior to study entry
- Hepatitis within 60 days prior to study entry
- Thyroid problems
- Drug or alcohol use which, in the opinion of the investigator, would interfere with the study
- Currently using experimental agents except when approved by the study
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
UCLA CARE Center CRS
Los Angeles, California, 90095, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, 90502-2052, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80262, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215, United States
SSTAR, Family Healthcare Ctr.
Fall River, Massachusetts, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455-0392, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63108, United States
Washington U CRS
St Louis, Missouri, 63108, United States
Beth Israel Med. Ctr., ACTU
New York, New York, 10003, United States
NY Univ. HIV/AIDS CRS
New York, New York, 10016, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267-0405, United States
MetroHealth CRS
Cleveland, Ohio, 44109-1998, United States
The Ohio State University Medical Center
Columbus, Ohio, 432101228, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104, United States
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, 02906, United States
Rhode Island Hosp.
Providence, Rhode Island, United States
Vanderbilt Therapeutics CRS
Nashville, Tennessee, 37203, United States
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, 775550435, United States
Related Publications (6)
Calza L, Manfredi R, Chiodo F. Dyslipidaemia associated with antiretroviral therapy in HIV-infected patients. J Antimicrob Chemother. 2004 Jan;53(1):10-4. doi: 10.1093/jac/dkh013. Epub 2003 Nov 25.
PMID: 14645323BACKGROUNDCalza L, Manfredi R, Chiodo F. Hyperlipidaemia in patients with HIV-1 infection receiving highly active antiretroviral therapy: epidemiology, pathogenesis, clinical course and management. Int J Antimicrob Agents. 2003 Aug;22(2):89-99. doi: 10.1016/s0924-8579(03)00115-8.
PMID: 12927947BACKGROUNDCarr A, Miller J, Law M, Cooper DA. A syndrome of lipoatrophy, lactic acidaemia and liver dysfunction associated with HIV nucleoside analogue therapy: contribution to protease inhibitor-related lipodystrophy syndrome. AIDS. 2000 Feb 18;14(3):F25-32. doi: 10.1097/00002030-200002180-00001.
PMID: 10716495BACKGROUNDMcComsey G. Update on mitochondrial toxicity of antiretrovirals and its link to lipodystrophy. AIDS Rev. 2002 Jul-Sep;4(3):140-7.
PMID: 12416448BACKGROUNDMallal SA, John M, Moore CB, James IR, McKinnon EJ. Contribution of nucleoside analogue reverse transcriptase inhibitors to subcutaneous fat wasting in patients with HIV infection. AIDS. 2000 Jul 7;14(10):1309-16. doi: 10.1097/00002030-200007070-00002.
PMID: 10930144BACKGROUNDTebas P, Zhang J, Hafner R, Tashima K, Shevitz A, Yarasheski K, Berzins B, Owens S, Forand J, Evans S, Murphy R. Peripheral and visceral fat changes following a treatment switch to a non-thymidine analogue or a nucleoside-sparing regimen in HIV-infected subjects with peripheral lipoatrophy: results of ACTG A5110. J Antimicrob Chemother. 2009 May;63(5):998-1005. doi: 10.1093/jac/dkp071. Epub 2009 Mar 19.
PMID: 19299471RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert L Murphy, MD
Northwestern University Medical Center
- STUDY CHAIR
Pablo Tebas, MD
University of Pennsylvania, Adult Clinical Trials Unit
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2001
First Posted
December 21, 2001
Study Start
March 1, 2002
Study Completion
March 1, 2005
Last Updated
July 29, 2013
Record last verified: 2013-07