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Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients Clinical research trials and Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients. Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients clinical trial. Human subjects often receive the most effective healthcare possible for their Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients  Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients
Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients
For Condition: Wasting Disease,Lipodystrophy,HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: Recent studies suggest body shape changes, fat redistribution, and fat lipoatrophy may be related to the NRTI component of patients' HAART and not to the protease inhibitor (PI) component. The hypothesis of this study is that thymidine analogues such as stavudine (d4T) and zidovudine (ZDV) cause lipoatrophy more so than non-thymidine analogues and that removal of thymidine analogues from HAART in patients with defined lipoatrophy will reverse this process. In Step 1, patients will undergo axial mid-thigh and abdomen computer tomography (CT) scans. If the CT scans are readable, patients are restrictively and randomly assigned to 1 of 2 treatment arms in Step 2. Patients in Arm A-1 will replace the thymidine analogue component (stavudine [d4T] or zidovudine [ZDV]) of their HAART with abacavir (ABC). Patients in Arm B-1 will discontinue their current HAART and will receive a PI and a nonnucleoside reverse transcriptase inhibitor (NNRTI), either lopinavir/ritonavir (LPV/r) and nevirapine (NVP) or atazanavir, ritonavir, and NVP. Patients currently on efavirenz (EFV) not provided by the study may choose to continue with EFV instead of switching to NVP. Comparisons will be made to the baseline values of subcutaneous fat measured by mid-thigh and abdominal CT. Patients in Arms A-1 and B-1 remain on study for a total of 48 weeks and do not advance to Step 3. Two additional groups (Arms A-2 and B-2) made no changes to HAART for 28 weeks to evaluate the natural history of change in lipoatrophy over time; accrual into these groups and into Step 3 has been discontinued. At Week 28, patients in Arms A-2 and B-2 were registered to Step 3 and switched from HAART to a designated new treatment. Arm A-2 patients will replace d4T or ZDV with ABC for 48 weeks. Arm B-2 patients replace their HAART with LPV/r plus NVP for 48 weeks. If patients in Arms A-2 and B-2 have not completed the 28-week delay and have not switched regimens, they will enter Step 4 and be reregistered into Arms A-1 and B-1, respectively, remaining on their treatment assignment for 48 weeks. If patients in Arms A-2 and B-2 have already switched regimens, then they will continue on their new regimens until Week 76.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Note: accrual into Arms A-2 and B-2 of this study has been discontinued. Inclusion Criteria for Step 1 - 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 Exclusion Criteria for Step 1 - 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
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
PabloTebas, Study Chair, University of Pennsylvania, Adult Clinical Trials Unit
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Harbor General / UCLA
Torrance, California, 90502-2052
United States
Comprehensive Care Clinic
Nashville, Tennessee, 37203
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Miriam Hosp / Family Healthcare Ctr at SSTAR
Providence, Rhode Island, 02906
United States
MetroHealth Med Ctr
Cleveland, Ohio, 44109-1998
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Washington Univ / St Louis Connect Care
St. Louis, Missouri, 63108
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Washington Univ School of Medicine
St. Louis, Missouri, 63108
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455-0392
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
The CORE Ctr
Chicago, Illinois, 60612
United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
University of Cincinnati
Cincinnati, Ohio, 45267-0405
United States
Additional Information:
Study ID Numbers: ACTG A5110; AACTG A5110
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028314
Other Lipodystrophy Studies:
1. Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients
Related Studies:
Other Lipodystrophy Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients
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