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CompletedNCT00002211Updated Jun 24, 2005

Safety and Effectiveness of Giving Combinations of Three or Four Anti-HIV Drugs to HIV-Infected Patients

An interventional study of Nelfinavir mesylate and Delavirdine mesylate in HIV Infections, sponsored by Pharmacia and Upjohn. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Pharmacia and Upjohn · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
160
Ages
18 Years and older
Sex
All
01

Study 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).

Read the detailed description

This is a multicenter, open-label study. Patients are stratified by HIV-1 RNA levels (20,000 to 200,000 copies/ml and greater than 200,000 copies/ml). Patients are equally randomized to one of four groups and receive antiretroviral therapy for 24 weeks. Group 1 receives delavirdine (DLV) plus nelfinavir (NFV) plus stavudine (d4T). Group 2 receives DLV plus NFV plus didanosine (ddI). Group 3 receives NFV plus d4T plus ddI. Group 4 receives DLV plus NFV plus d4T plus ddI. Patients are evaluated for drug safety and viral burden. Patients may opt to continue on the study for 24 additional weeks, at the discretion of the investigator.

02

Conditions studied

  • HIV Infections

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Keywords

  • HIV-1
  • Didanosine
  • Stavudine
  • HIV Protease Inhibitors
  • RNA, Viral
  • Delavirdine
  • Reverse Transcriptase Inhibitors
  • Viral Load
  • Nelfinavir
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 160 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Pharmacia and Upjohn is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Enrollment
160 participants

Interventions

  • DrugNelfinavir mesylate
  • DrugDelavirdine mesylate
  • DrugStavudine
  • DrugDidanosine
06

Study locations

1 site
  • Pharmacia & Upjohn
    Peapack, New Jersey 07977, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002211
Lead sponsor
Pharmacia and Upjohn
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2000. You cannot join it, but the record below documents what was studied.

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