NCT00021463

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for phase_2 hiv-infections

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2001

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2002

Completed
Last Updated

February 28, 2011

Status Verified

January 1, 2003

First QC Date

July 14, 2001

Last Update Submit

February 24, 2011

Conditions

HIV InfectionsLipodystrophy

Keywords

NevirapineReverse Transcriptase InhibitorsAnti-HIV AgentsTriglyceridesabacavirefavirenzLipoproteins, LDL Cholesterol

Interventions

Abacavir sulfate, Lamivudine and ZidovudineDRUG
Abacavir sulfateDRUG
EfavirenzDRUG
NevirapineDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, 20007, United States

Location

Emory Univ

Atlanta, Georgia, 30308, United States

Location

Northwestern Univ Med School

Chicago, Illinois, 60611, United States

Location

The CORE Ctr

Chicago, Illinois, 60612, United States

Location

Boston Med Ctr

Boston, Massachusetts, 02118, United States

Location

Brigham and Women's Hosp

Boston, Massachusetts, 02215, United States

Location

Beth Israel Med Ctr

New York, New York, 10003, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Univ of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Univ of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

HIV InfectionsLipodystrophy

Interventions

abacavirLamivudineZidovudineefavirenzNevirapine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidinePyridines

Study Officials

  • David Wohl

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 14, 2001

First Posted

August 31, 2001

Primary Completion

February 1, 2002

Last Updated

February 28, 2011

Record last verified: 2003-01

Locations

US(11)