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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002245
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Abacavir sulfate Drug: Amprenavir Drug: Lamivudine Phase 3

Detailed Description:
This single-site study uses an open-label, single-arm design to evaluate the effects of APV, a protease inhibitor (PI), plus concurrent nucleoside reverse transcriptase inhibitors (NRTIs) ABC and 3TC on carbohydrate and lipid metabolism in non-diabetic, HIV-1 infected patients initiating antiretroviral therapy. Treatment duration is 24 weeks, and patients serve as their own controls. The combination therapy is evaluated for safety, tolerability, efficacy, and effects on body composition. The proportion of patients who attain plasma HIV RNA below the lower limit of quantitation of the Roche Amplicor (less than 400 copies/ml) and Ultrasensitive (less than 50 copies/ml) is measured at 24 weeks after starting therapy with APV plus ABC plus 3TC.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Amprenavir on Carbohydrate and Lipid Metabolism in Patients With HIV Infection
Study Start Date : April 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Amprenavir

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002245

United States, California
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Glaxo Wellcome
Study Chair: M Dube Identifier: NCT00002245     History of Changes
Other Study ID Numbers: 264L
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: August 2000

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
VX 478
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Insulin Resistance

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents