A Study of the Effects of Amprenavir, a Protease Inhibitor, on Carbohydrate and Fat Metabolism in HIV-Infected Patients

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

Summary

The purpose of this study is to evaluate the effects of a 3-drug anti-HIV regimen, amprenavir (APV) plus abacavir (ABC) plus lamivudine (3TC), on the way carbohydrates (sugars) and fats are metabolized (processed by the body) in HIV-infected patients who have received little or no previous anti-HIV drug therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Abacavir; Amprenavir; HIV Protease Inhibitors; Lamivudine; Protease Inhibitors

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Are at least 18 years old.

• Have very little or no anti-HIV drug experience (see below for details) and have never taken ABC.

• Have a CD4 count greater than or equal to 200 cells/mm3 within 30 days prior to study entry.

• Have a viral load (level of HIV in the blood) greater than 500 copies/ml within 30 days prior to study entry.

• Agree to use effective methods of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have taken both 3TC and stavudine (d4T).

• Have taken a protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) for more than 7 days.

• Have taken a PI within 60 days of study entry.

• Have a history of diabetes.

• Have a history of untreated gonad or thyroid disorder.

• Have a stomach or intestinal disorder which may affect the way the body absorbs the study drugs, or which may make them unable to take medications by mouth.

• Have received chemotherapy or radiation within 4 weeks prior to entry, or if they will need either of these during the study period.

• Have lost or gained a significant amount of weight (greater than 5%) within the past 2 months.

• Have a serious medical condition, such as heart disease.

• Are allergic to any of the study drugs.

• Have been treated for an infection or other medical illness within 14 days prior to study entry.

• Have had a fever (over 38.5 degrees Celsius) for any 7 days or chronic diarrhea (more than 3 liquid stools per day for 15 days) within 30 days prior to study entry.

• Have an AIDS-related cancer (other than Kaposi's sarcoma).

• Abuse alcohol or drugs.

• Have received certain medications.

• Are pregnant.