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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002245
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 2000
  Purpose

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 Intervention Phase
HIV Infections
Drug: Abacavir sulfate
Drug: Amprenavir
Drug: Lamivudine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Amprenavir on Carbohydrate and Lipid Metabolism in Patients With HIV Infection

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Study Start Date: April 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002245

Locations
United States, California
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Glaxo Wellcome
Investigators
Study Chair: M Dube
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002245     History of Changes
Other Study ID Numbers: 264L, COL30309
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
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
Abacavir
Reverse Transcriptase Inhibitors
Lamivudine
Amprenavir
HIV Protease Inhibitors
Protease Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 30, 2014