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Changing to Nonprotease Inhibitor Treatment to Improve Side Effects

Primary Purpose

HIV Infections, Lipodystrophy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Abacavir sulfate, Lamivudine and Zidovudine
Abacavir sulfate
Efavirenz
Nevirapine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Nevirapine, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Triglycerides, abacavir, efavirenz, Lipoproteins, LDL Cholesterol

Eligibility Criteria

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

Inclusion Criteria Patients may be eligible for this study if they: Are HIV infected. Are on their first combination of stable anti-HIV drugs (have not changed drugs for at least 6 months, except for reasons other than failing treatment or short interruptions of less than 7 days). Have 2 measurements of viral load (amount of HIV in the blood) during the 6 months before entering the study that are below 400 copies/ml by RT-PCR test or below 500 copies/ml by branched DNA test, measured at least 8 weeks apart. Have a viral load below 50 copies/ml within 30 days prior to entry. Have a CD4 cell count of 200 copies/ml or higher within 60 days of study entry. Are receiving medications and/or medications at certain doses that might interfere with the study. Are at least 13 years old and have signed consent of parent or guardian if under 18 years of age. Have a negative pregnancy test within 14 days of study entry, if a woman able to have children. Agree to use a barrier method of birth control, men and women, while receiving study drugs and for 3 months afterwards. Exclusion Criteria Patients will not be eligible for this study if they: Are receiving high doses of testosterone. Low doses are allowed if received for 60 or more days before entering the study with no plans to change the dose during the first 24 weeks of the study. Have had treatment with any nonnucleoside reverse transcriptase inhibitor (NNRTI). Have had treatment with ABC. Are allergic to study drugs or any ingredient in them. Are pregnant or breast-feeding. Have used any HIV vaccine or drugs affecting the immune system within 30 days prior to entering the study. Have had systemic treatment for cancer within 30 days of entering the study. Have had systemic treatment with certain other drugs that may interfere with the study within 14 days of entering the study. Have a serious illness that required systemic treatment or a hospital stay unless treatment was completed at least 14 days prior to entering the study, or are on stable treatment, in the doctor's opinion, for at least 14 days prior to entering the study. Abuse drugs or alcohol. Have or suspect they have acute hepatitis within 30 days of entering the study.

Sites / Locations

  • Univ of Alabama at Birmingham
  • Georgetown Univ Med Ctr
  • Emory Univ
  • Northwestern Univ Med School
  • The CORE Ctr
  • Boston Med Ctr
  • Brigham and Women's Hosp
  • Beth Israel Med Ctr
  • Bellevue Hosp / New York Univ Med Ctr
  • Univ of Pennsylvania
  • Univ of Pittsburgh

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 14, 2001
Last Updated
February 24, 2011
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00021463
Brief Title
Changing to Nonprotease Inhibitor Treatment to Improve Side Effects
Official Title
Phase II, Randomized, Open-Label Study of Switching to Protease Inhibitor-Sparing Regimens for Improvement of Metabolic Abnormalities
Study Type
Interventional

2. Study Status

Record Verification Date
January 2003
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to learn whether changing from a type of anti-HIV drug called a protease inhibitor (PI) to another type of anti-HIV drug will help to lower the amount of fats or sugars in the blood. PIs have been effective at keeping HIV viral load (amount of HIV in the blood) down. However, some people who take PIs have higher than normal levels of fats and/or sugars in the blood. Doctors believe that switching to anti-HIV drugs that do not contain PIs will improve the abnormal side effects. This study will test 3 different combinations of non-PI drugs to see which may improve side effects while keeping viral loads low.
Detailed Description
Protease inhibitor (PI)-containing antiretroviral regimens are potent suppressors of HIV replication. Increasingly, metabolic abnormalities such as hypercholesterolemia and triglyceridemia are associated with PI use, reasons cited for switching to PI-sparing regimens. Yet optimal switch regimens that take into account both improvements in side effects and continued virologic suppression have not been defined. This study will compare the effect on chemical metabolic abnormalities of switching to an all nucleoside regimen versus dual nucleoside plus nonnucleoside reverse transcriptase inhibitor (NNRTI) therapy. Determining the effects of each regimen on chemical metabolic abnormalities and maintenance of virologic suppression will define which of the switch strategies being studied improves metabolic abnormalities without compromising viral suppression. Patients are stratified on the basis of fasting non-HDL cholesterol and triglyceride levels and on ritonavir- or nonritonavir-containing pre-entry PI regimens. Patients are assigned randomly to add to their pre-entry regimen 1 of the following 3 treatments: Arm A - ABC; Arm B - NVP; or Arm C - EFV. Patients discontinue pre-entry PIs after Day 14. Patients are followed to determine the effect of the maintenance regimens on fasting non-high-density lipoprotein (HDL), cholesterol, and triglycerides at Week 24. Fasting total cholesterol, HDL cholesterol, direct low-density lipoprotein, and triglycerides are measured at Weeks 12, 24, and 48. Fasting glucose, insulin, C-peptide, apolipoproteins A-1 and B, lipoprotein a, and homocysteine are measured at Weeks 24 and 48. Anthropometrics, body mass index, and body image are measured at Weeks 12, 24, and 48. HIV viral load is measured at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. If HIV RNA stays below 200 copies/ml, therapy continues unchanged. If confirmed HIV RNA of 200 copies/ml or higher is found, an HIV genotype is obtained providing the viral load is sufficient to yield results, the best medical therapy is instituted (not supplied by the study), and off treatment/on study follow-up is continued. If patients are intolerant to a study drug, an alternate study drug (ABC, EFV, or NVP supplied by the study) is permitted and switched treatment/on study follow-up continued, or the best medical therapy is instituted (not supplied by the study), and off treatment/on study follow-up is continued. Patients are followed until the last patient enrolled has completed 48 weeks on study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Lipodystrophy
Keywords
Nevirapine, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Triglycerides, abacavir, efavirenz, Lipoproteins, LDL Cholesterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
342 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate, Lamivudine and Zidovudine
Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Intervention Type
Drug
Intervention Name(s)
Nevirapine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Are HIV infected. Are on their first combination of stable anti-HIV drugs (have not changed drugs for at least 6 months, except for reasons other than failing treatment or short interruptions of less than 7 days). Have 2 measurements of viral load (amount of HIV in the blood) during the 6 months before entering the study that are below 400 copies/ml by RT-PCR test or below 500 copies/ml by branched DNA test, measured at least 8 weeks apart. Have a viral load below 50 copies/ml within 30 days prior to entry. Have a CD4 cell count of 200 copies/ml or higher within 60 days of study entry. Are receiving medications and/or medications at certain doses that might interfere with the study. Are at least 13 years old and have signed consent of parent or guardian if under 18 years of age. Have a negative pregnancy test within 14 days of study entry, if a woman able to have children. Agree to use a barrier method of birth control, men and women, while receiving study drugs and for 3 months afterwards. Exclusion Criteria Patients will not be eligible for this study if they: Are receiving high doses of testosterone. Low doses are allowed if received for 60 or more days before entering the study with no plans to change the dose during the first 24 weeks of the study. Have had treatment with any nonnucleoside reverse transcriptase inhibitor (NNRTI). Have had treatment with ABC. Are allergic to study drugs or any ingredient in them. Are pregnant or breast-feeding. Have used any HIV vaccine or drugs affecting the immune system within 30 days prior to entering the study. Have had systemic treatment for cancer within 30 days of entering the study. Have had systemic treatment with certain other drugs that may interfere with the study within 14 days of entering the study. Have a serious illness that required systemic treatment or a hospital stay unless treatment was completed at least 14 days prior to entering the study, or are on stable treatment, in the doctor's opinion, for at least 14 days prior to entering the study. Abuse drugs or alcohol. Have or suspect they have acute hepatitis within 30 days of entering the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Wohl
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Emory Univ
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The CORE Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Boston Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Brigham and Women's Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Univ of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Univ of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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Changing to Nonprotease Inhibitor Treatment to Improve Side Effects

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