Effect of a Change in HIV Therapy on Liver Steatosis, Inflammation, and Fibrosis

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to look at how 2 different anti-HIV drug treatments affect the liver.

The use of anti-HIV drugs like the nucleoside reverse transcriptase inhibitors (NRTIs) may be linked to liver problems like fatty changes, scarring, abnormal liver function tests (LFTs), and lactic acidemia (an increase in lactic acid in the blood). Increased liver enzymes may mean liver damage. The way that the liver changes in people with abnormal LFTs and lactic acidemia is not completely understood.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Efavirenz; Lopinavir; Reverse Transcriptase Inhibitors; Ritonavir

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Have a higher than normal level of lactic acid and liver enzymes in blood within 45 days prior to study entry.

• Are HIV infected.

• Have been receiving an anti-HIV drug combination containing an NRTI for more than 12 months continuously before entering the study.

• Have an HIV viral load (amount of HIV in the blood) of less than 200 copies/ml within 70 days prior to study entry.

• Have a negative pregnancy test within 45 days prior to study entry.

• Agree to use 2 approved methods of birth control while participating in sexual activity that could lead to pregnancy, while receiving study medications and for 6 weeks after stopping the medications, both men and women and their partners, if able to have children.

• Are at least 13 years of age.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have hepatitis B according to certain lab tests.

• Have known causes for liver disease other than HCV or anti-HIV therapy.

• Regularly and excessively use alcohol.

• Are unwilling to restrict alcohol use to the amount allowed during the study.

• Have untreated endocrine disease such as diabetes and Cushing's disease. Diabetes that is under good control, stable hypothyroidism on replacement therapy, and stable hypogonadism on replacement therapy will be allowed.

• Receive prednisone within 1 month of study entry or high levels of prednisone (greater than 10 mg/day) within 90 days of study entry.

• Have had poorly controlled congestive heart failure within the last 12 months.

• Have signs and symptoms of abnormal liver function.

• Are unwilling to have a liver biopsy.

• Have a swollen abdomen due to accumulated fluid.

• Are suspected of having liver cancer.

• Are pregnant and breast-feeding.

• Abuse drugs.

• Have a serious illness within 14 days prior to entry.

• Have an AIDS-related (opportunistic) infection or illness at the time of study entry.

• Have HIV resistance to certain anti-HIV drugs.

• Have a history of failing treatment with PI-containing drugs (not due to side effects of the drug).

• Have previously received NNRTI medications (except for current drug combination that is successful).

• Have used certain drugs within 30 days prior to study entry.

• Are allergic to any of the study drugs.

• Are receiving or may need to receive treatment for hepatitis C during the study.

• Have previously enrolled in A5116.