search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Abacavir sulfate
Amprenavir
Lamivudine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Carbohydrates, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Lipids, Insulin Resistance, abacavir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LAC / USC Med Ctr / Infectious Diseases

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
search

1. Study Identification

Unique Protocol Identification Number
NCT00002245
Brief Title
A Study of the Effects of Amprenavir, a Protease Inhibitor, on Carbohydrate and Fat Metabolism in HIV-Infected Patients
Official Title
Effect of Amprenavir on Carbohydrate and Lipid Metabolism in Patients With HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2000
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Carbohydrates, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Lipids, Insulin Resistance, abacavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Amprenavir
Intervention Type
Drug
Intervention Name(s)
Lamivudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Dube
Official's Role
Study Chair
Facility Information:
Facility Name
LAC / USC Med Ctr / Infectious Diseases
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs