NCT00002400

Brief Summary

The purpose of this study is to compare the safety and effectiveness of giving HIV-infected patients delavirdine (DLV) plus zidovudine (ZDV) plus 2 doses of indinavir (IDV) or ZDV plus IDV plus lamivudine (3TC). This study also examines how the body processes DLV when it is given in combination with other drugs.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at below P25 for not_applicable hiv-infections

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

January 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

HIV-1Drug Therapy, CombinationZidovudineHIV Protease InhibitorsLamivudineIndinavirRNA, ViralDelavirdineReverse Transcriptase Inhibitors

Interventions

Indinavir sulfateDRUG
Delavirdine mesylateDRUG
LamivudineDRUG
ZidovudineDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have:
  • HIV-1 positive.
  • CD4 count above 50.
  • HIV-1 RNA greater than 20,000.
  • Prior Medication:
  • Allowed:
  • Less than 1 month prior treatment with zidovudine.

You may not qualify if:

  • Prior Medication:
  • Excluded:
  • Prior 3TC, protease inhibitors, or non-nucleoside reverse transcriptase inhibitors.
  • Prior ZDV of greater than 1 month total duration.
  • Prior Treatment:
  • Excluded:
  • Lamivudine.
  • Protease inhibitors.
  • Non-nucleoside reverse transcriptase inhibitors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmacia & Upjohn

Peapack, New Jersey, 07977, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

IndinavirDelavirdineLamivudineZidovudine

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)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

Study Design

Study Type
interventional
Phase
not applicable
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: 1999-01

Locations

US(1)