NCT00002216

Brief Summary

The purpose of this study is to compare 2 combination drug therapies in HIV-infected patients who have never received anti-HIV treatment.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

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

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationHIV Protease InhibitorsVX 478Reverse Transcriptase InhibitorsAnti-HIV Agentsabacavir

Interventions

Lamivudine/ZidovudineDRUG
Abacavir sulfateDRUG
AmprenavirDRUG
Nelfinavir mesylateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • CD4 count \> 50.
  • HIV RNA \> 5,000.
  • No active AIDS (excluding CD4 count \< 200).
  • Ability to comply with dosing schedule and protocol evaluations.
  • Prior Medication:
  • Allowed:
  • TC or any protease inhibitor, if \< 1 week of therapy.
  • Other nucleoside analogs, if \< 4 weeks of therapy.

You may not qualify if:

  • Co-existing Condition:
  • Patients with any of the following symptoms or conditions are excluded:
  • Active AIDS (not including CD4 count \< 200).
  • Malabsorption syndrome affecting drug absorption.
  • Concurrent Medication:
  • Excluded:
  • Enrollment in any other investigational drug protocol.
  • Prior Medication:
  • Excluded:
  • Non-nucleoside reverse transcriptase inhibitors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anderson Clinical Research

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

lamivudine, zidovudine drug combinationabacaviramprenavirNelfinavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1999-05

Locations

US(1)