NCT00005002

Brief Summary

The purpose of this study is to see if it is effective to add an HIV vaccine (Remune) to the anti-HIV drug combination of Combivir (zidovudine plus lamivudine) and nelfinavir.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
688

participants targeted

Target at P50-P75 for phase_3 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

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

August 1, 2001

First QC Date

March 21, 2000

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

HIV-1Drug Therapy, CombinationHIV Protease InhibitorsCD4 Lymphocyte CountNelfinavirReverse Transcriptase InhibitorsAnti-HIV AgentsViral LoadremuneCombivir

Interventions

Lamivudine/ZidovudineDRUG
HIV-1 ImmunogenBIOLOGICAL
Nelfinavir mesylateDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are HIV-positive.
  • Are at least 13 years old (consent of parent or guardian required if under 18).
  • Have a viral load of at least 10,000 copies/ml.
  • Have a CD4 count of at least 250 cells/mm3.
  • Have never taken any anti-HIV drugs before.

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

lamivudine, zidovudine drug combinationHIV-1 immunogen, incomplete Freund's adjuvantNelfinavir

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 Compounds

Study Design

Study Type
interventional
Phase
phase 3
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 21, 2000

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 2001-08

Locations

US(1)