NCT00002367

Brief Summary

To evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3 hiv-infections

Geographic Reach
1 country

2 active sites

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

August 1, 1997

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationAcquired Immunodeficiency SyndromeZidovudineHIV Protease InhibitorsLamivudineSaquinavirReverse Transcriptase InhibitorsAnti-HIV Agents

Interventions

SaquinavirDRUG
LamivudineDRUG
ZidovudineDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • Plasma HIV-1 RNA titers \> 10,000 copies/ml.
  • CD4 cell count \> 100 cells/mm3.

You may not qualify if:

  • Co-existing Condition:
  • Patients with any of the following conditions will be excluded:
  • Any prior anti-retroviral drug therapy.
  • Prior Medication:
  • Excluded:
  • Previous anti-retroviral drug therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AIDS Healthcare Foundation Labs

Los Angeles, California, 90048, United States

Location

Urgent Care Ctr / North Broward Hosp District

Fort Lauderdale, Florida, 33316, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

SaquinavirLamivudineZidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinolinesZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1997-08

Locations

US(2)