Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Abacavir; Atazanavir Sulfate; Lopinavir; Nevirapine; Ritonavir

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