NCT00005000

Brief Summary

The purpose of this study is to compare two drugs (nelfinavir \[NFV\] and efavirenz \[EFV\]) used in start-up anti-HIV treatment. Doctors want to see if one is better than the other in extending the time that viral load (level of HIV in the blood) is kept low. The study will also look at the response of the immune system to each drug.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2000

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2002

First QC Date

March 21, 2000

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

HIV-1Drug Therapy, CombinationLymphoid TissueHIV Protease InhibitorsGenotypePhenotypeNelfinavirReverse Transcriptase InhibitorsAnti-HIV AgentsViral LoadAdipose TissueGlucoseLipidsImmunophenotypingefavirenz

Interventions

Nelfinavir mesylateDRUG
EfavirenzDRUG
LamivudineDRUG
Keyhole-Limpet HemocyaninDRUG
StavudineDRUG
ZidovudineDRUG
DidanosineDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients may be eligible for this trial if they:
  • Are HIV-positive.
  • Have a CD4 count of at least 100 cells/mm3.
  • Have a viral load of at least 5,000 copies/ml.

You may not qualify if:

  • Patients may not be eligible for this study if they:
  • Have taken any antiretroviral (anti-HIV) agent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agouron Pharmaceuticals Inc

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

NelfinavirefavirenzLamivudinekeyhole-limpet hemocyaninStavudineZidovudineDidanosine

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 CompoundsZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidineInosinePurine NucleosidesPurinesRibonucleosides

Study Design

Study Type
interventional
Phase
phase 4
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 21, 2000

First Posted

August 31, 2001

Study Start

December 1, 1999

Last Updated

June 24, 2005

Record last verified: 2002-07

Locations

US(1)