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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002245

Run by

Glaxo Wellcome

Starts

1999-04-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• LAC / USC Med Ctr / Infectious Diseases — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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