NCT00002217

Brief Summary

The purpose of this study is to test the effectiveness of Combivir plus abacavir plus 141W94 in patients who previously have used anti-HIV drugs.

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, CombinationPatient ComplianceAnti-HIV Agentsabacavir

Interventions

Lamivudine/ZidovudineDRUG
Abacavir sulfateDRUG
AmprenavirDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have:
  • CD4 count greater than 50 cells/mm3.
  • HIV RNA less than 50,000 copies/ml.
  • No active AIDS (excluding CD4 count less than 200 cells/mm3).
  • Ability to comply with dosing schedule and protocol evaluations.
  • Prior Medication:
  • Allowed:
  • AZT or non-nucleoside reverse transcriptase inhibitors (NNRTIs).

You may not qualify if:

  • Co-existing Condition:
  • Patients with any of the following symptoms or conditions are excluded:
  • Active AIDS (not excluding CD4 count less than 200).
  • Malabsorption syndrome affecting drug absorption.
  • Serious medical condition that would compromise safety of the patient.
  • Concurrent Medication:
  • Excluded:
  • AZT or NNRTIs.
  • More than 1 week treatment with any protease inhibitor.
  • Enrollment in any other investigational drug protocol.
  • Patients with the following prior conditions are excluded:
  • History of clinically relevant pancreatitis or hepatitis within the past 6 months.
  • Required:
  • Antiretroviral therapy with either single or double reverse transcriptase inhibitors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anderson Clinical Research

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • Henry K, Shaeffer M, Ross L, Johnson M, Fisher R, Liao Q, Graham N. Response to Combivir and abacavir given bid to nucleoside experienced patients is not affected by the presence of the M184V mutation. 6th Conf Retro and Opportun Infect. 1999 Jan 31 - Feb 4 (abstract no 132)

    BACKGROUND

  • Henry K, Wallace RJ, Bellman PC, Norris D, Fisher RL, Ross LL, Liao Q, Shaefer MS; TARGET Study Team. Twice-daily triple nucleoside intensification treatment with lamivudine-zidovudine plus abacavir sustains suppression of human immunodeficiency virus type 1: results of the TARGET Study. J Infect Dis. 2001 Feb 15;183(4):571-8. doi: 10.1086/318527. Epub 2001 Jan 11.

    PMID: 11170982BACKGROUND

MeSH Terms

Conditions

HIV InfectionsPatient Compliance

Interventions

lamivudine, zidovudine drug combinationabacaviramprenavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

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)