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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00028314 |
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Date of registration:
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20/12/2001 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients
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Scientific title:
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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 |
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Date of first enrolment:
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March 2002 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00028314 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Robert L Murphy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Northwestern University Medical Center |
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Name:
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Pablo Tebas, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pennsylvania, Adult Clinical Trials Unit |
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Key inclusion & exclusion criteria
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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
Age minimum:
13 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Wasting Disease
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Lipodystrophy
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Intervention(s)
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Drug: Nevirapine
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Drug: Abacavir sulfate
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Drug: Atazanavir/Ritonavir
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Drug: Lopinavir/Ritonavir
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Secondary ID(s)
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AACTG A5110
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ACTG A5110
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A5110
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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