NCT00002171

Brief Summary

The purpose of this study is to see if it is safe and effective to give Viracept plus stavudine (d4T) plus lamivudine (3TC) to HIV-positive women with a CD4 count \<= 400 cells/mm3. This study also examines how the body handles Viracept when given with d4T and 3TC.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

4 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

May 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

PlacebosDrug Therapy, CombinationStavudineHIV Protease InhibitorsLamivudineNelfinavirAnti-HIV Agents

Interventions

Nelfinavir mesylateDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have:
  • HIV infection.
  • CD4 T cell count \<= 400 cells/mm3.

You may not qualify if:

  • Prior Medication:
  • Excluded:
  • Prior therapy or less than 1 month of therapy with d4T and/or 3TC.
  • Prior protease inhibitor therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Univ of Southern California / LA County USC Med Cntr

Los Angeles, California, 90033, United States

Location

HIV Outpatient Clinics / LA State Univ Med Ctr

New Orleans, Louisiana, 70112, United States

Location

Baylor Univ

Houston, Texas, 77009, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Nelfinavir

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 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: 1999-05

Locations

US(4)