NCT00002211

Brief Summary

The purpose of this study is to see if it is safe and effective to give combinations of three or four anti-HIV drugs to HIV-infected patients. The drugs used in this study are delavirdine (DLV), nelfinavir (NLF), didanosine (ddI), and stavudine (d4T).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P25-P50 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

April 1, 2000

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

HIV-1DidanosineStavudineHIV Protease InhibitorsRNA, ViralDelavirdineReverse Transcriptase InhibitorsViral LoadNelfinavir

Interventions

Nelfinavir mesylateDRUG
Delavirdine mesylateDRUG
StavudineDRUG
DidanosineDRUG

Eligibility Criteria

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

You may qualify if:

  • You may be eligible for this study if you:
  • Are at least 18 years old.
  • Are HIV-positive.
  • Have a CD4 count of at least 50 cells/mm3.
  • Have a viral load of at least 20,000 copies/ml.

You may not qualify if:

  • You will not be eligible for this study if you:
  • Have taken d4T.
  • Have taken protease inhibitors, including NFV.
  • Have taken nonnucleoside reverse transcriptase inhibitors.
  • Have taken ddI for 1 month or more.

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

NelfinavirDelavirdineStavudineDidanosine

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 CompoundsPiperazinesHeterocyclic Compounds, 1-RingIndolesThymidinePyrimidine NucleosidesPyrimidinesDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesInosinePurine NucleosidesPurinesRibonucleosides

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: 2000-04

Locations

US(1)