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

NCT00002245 | Completed Phase 3

• 2 other identifiers: 264LCOL30309
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Drug Therapy, Combination; HIV Protease Inhibitors; Lamivudine; Carbohydrates; VX 478; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Lipids; Insulin Resistance; abacavir

Interventions

Abacavir sulfate DRUG

Amprenavir DRUG

Lamivudine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Glaxo Wellcome: lead

Study Sites (1)

LAC / USC Med Ctr / Infectious Diseases

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

HIV Infections; Insulin Resistance

Interventions

abacavir; amprenavir; Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• M Dube

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Start: April 1, 1999
• Last Updated: June 24, 2005

Record last verified: 2000-08

Locations

US (1)