NCT00002190

Brief Summary

To explore the antiviral efficacy, tolerability and safety of saquinavir plus zidovudine plus lamivudine.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_2 hiv-infections

Geographic Reach
1 country

3 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

July 1, 1997

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationZidovudineHIV Protease InhibitorsLamivudineSaquinavirReverse Transcriptase InhibitorsAnti-HIV Agents

Interventions

SaquinavirDRUG
LamivudineDRUG
ZidovudineDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have:
  • HIV antibody positive.
  • CD4 count \>= 150 and \<= 500 cells/mm3.

You may not qualify if:

  • Prior Medication:
  • Excluded:
  • Prior antiretroviral therapy.
  • Prior protease inhibitor therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Davies Med Ctr / c/o HIV Institute

San Francisco, California, 94114, United States

Location

Pacific Oaks Med Group / Rsch & Scientific Investigation

Sherman Oaks, California, 91403, United States

Location

Columbia Presbyterian Med Ctr

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

SaquinavirLamivudineZidovudine

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 CompoundsQuinolinesZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

Study Design

Study Type
interventional
Phase
phase 2
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: 1997-07

Locations

US(3)