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Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients

Primary Purpose

HIV Infections

Status
Suspended
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lamivudine/Zidovudine
Capravirine
Nelfinavir mesylate
Sponsored by
Agouron Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, Disease Progression, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Nelfinavir, Combivir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients may be eligible if they: Are HIV-positive. Are at least 18 years old. Have a CD4 cell count of more than 50 cells/mm3. Have an HIV level of more than 5000 copies/ml. Exclusion Criteria Patients will not be eligible if they: Have ever taken any of the following anti-HIV drugs: nonnucleoside reverse transcriptase inhibitors (NNRTIs), AG1549, Viracept, zidovudine, lamivudine, or Combivir. Other anti-HIV drugs are allowed only if taken for no more than 30 days with the last dose taken more than 6 months prior to study entry. Have taken an experimental drug within 28 days of study entry.

Sites / Locations

  • Arizona Clinical Research Ctr Inc
  • Univ of Southern California
  • Highland Gen Hosp / San Francisco Gen Hosp
  • ViRx Inc
  • Research & Treatment at the California Pacific Med Ctr
  • Harbor - UCLA Med Ctr
  • IDC Research Initiative
  • Bach and Godofsky
  • Community Health Care
  • Univ of Florida
  • Univ of Miami School of Medicine
  • South Shore Hosp
  • Specialty Med Care Ctrs of South Florida Inc
  • Orange County Health Dept
  • Larry Bush
  • Infectious Diseases Associates
  • Infectious Disease Research Institute
  • Treasure Coast Infectious Disease Consultants
  • Polk County Health Dept
  • Sky Blue
  • Northwestern Univ Med Ctr
  • The CORE Ctr
  • Indiana Univ Infectious Disease Research Clinic
  • Univ of Iowa
  • Univ of Kansas School of Medicine
  • University of Louisville / ID Division
  • HIV Outpatient Clinics / LA State Univ Med Ctr
  • Fenway Community Health Ctr
  • Hawthorne Med Associates / PAACA
  • Kansas City AIDS Research Consortium
  • Univ of Nebraska Medical Ctr
  • Paul Alessi
  • VAMC New Jersey Healthcare System
  • St Mary's Hosp Family Treatment Ctr
  • Univ of Med & Dentistry of New Jersey
  • Bentley-Salick Medical Practice PC
  • Univ of Rochester Med Ctr
  • Univ of Cincinnati / Holmes Hosp
  • Med Univ of South Carolina
  • Julio Arroyo
  • Southwest Infectious Diseases Associates
  • Univ TX Galveston Med Branch
  • Joseph C Gathe
  • Thomas Street Clinic
  • Hampton Roads Med Specialists
  • Wisconsin AIDS Research Consortium
  • Canadian HIV Trials Network
  • QEII Health Science Centre
  • Sunnybrook Health Science Centre
  • Montreal Chest Institute
  • Immunity Care and Research Inc
  • Univ of Puerto Rico School of Med
  • Clinical Research Puerto Rico Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 21, 2000
Last Updated
June 23, 2005
Sponsor
Agouron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00004999
Brief Title
Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of AG1549 in Combination With Viracept (Nelfinavir Mesylate) and Combivir (Zidovudine + Lamivudine) in Treatment-Naive HIV-Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2001
Overall Recruitment Status
Suspended
Study Start Date
August 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Agouron Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to look at the effectiveness of giving a new anti-HIV drug (AG1549) plus Viracept (nelfinavir) plus Combivir (a tablet containing zidovudine plus lamivudine) to HIV-infected patients who are not taking anti-HIV drugs.
Detailed Description
[Note: As of 2/28/2001, due to toxicity studies and concerns for safety, sites were notified that they need to discontinue patients from the capravirine/placebo arms and continue patients with their background therapies or switch patients to new therapies, as deemed appropriate by the investigators.] Patients are randomized to receive Viracept plus Combivir plus either AG1549 or placebo. Patients remain on their assigned therapy for 48 weeks with one post-therapy follow-up visit. Blood samples are taken regularly to quantify plasma HIV-1 RNA, CD4 and CD8 counts, and peripheral blood mononuclear cells (PBMC). Physical exams, safety assessments, and other tests are also done throughout the study. A blood sample is taken at baseline (pre-dose) for a pharmacokinetics assessment. On Day 8 and at the end of Weeks 4, 8, 16, 24, 36, and 48, pharmacokinetic sampling is done prior to dosing and between 2 to 4 hours post-dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, Disease Progression, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Nelfinavir, Combivir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
350 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamivudine/Zidovudine
Intervention Type
Drug
Intervention Name(s)
Capravirine
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients may be eligible if they: Are HIV-positive. Are at least 18 years old. Have a CD4 cell count of more than 50 cells/mm3. Have an HIV level of more than 5000 copies/ml. Exclusion Criteria Patients will not be eligible if they: Have ever taken any of the following anti-HIV drugs: nonnucleoside reverse transcriptase inhibitors (NNRTIs), AG1549, Viracept, zidovudine, lamivudine, or Combivir. Other anti-HIV drugs are allowed only if taken for no more than 30 days with the last dose taken more than 6 months prior to study entry. Have taken an experimental drug within 28 days of study entry.
Facility Information:
Facility Name
Arizona Clinical Research Ctr Inc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Univ of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Highland Gen Hosp / San Francisco Gen Hosp
City
Oakland
State/Province
California
ZIP/Postal Code
946021018
Country
United States
Facility Name
ViRx Inc
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Research & Treatment at the California Pacific Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Bach and Godofsky
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Community Health Care
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Univ of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
South Shore Hosp
City
Miami
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Facility Name
Specialty Med Care Ctrs of South Florida Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Orange County Health Dept
City
Orlando
State/Province
Florida
ZIP/Postal Code
32805
Country
United States
Facility Name
Larry Bush
City
Palm Springs
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Infectious Diseases Associates
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Infectious Disease Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Treasure Coast Infectious Disease Consultants
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Polk County Health Dept
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33881
Country
United States
Facility Name
Sky Blue
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Northwestern Univ Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The CORE Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
University of Louisville / ID Division
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
HIV Outpatient Clinics / LA State Univ Med Ctr
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Fenway Community Health Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Hawthorne Med Associates / PAACA
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02745
Country
United States
Facility Name
Kansas City AIDS Research Consortium
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Univ of Nebraska Medical Ctr
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
681985400
Country
United States
Facility Name
Paul Alessi
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
VAMC New Jersey Healthcare System
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
St Mary's Hosp Family Treatment Ctr
City
Hoboken
State/Province
New Jersey
ZIP/Postal Code
07030
Country
United States
Facility Name
Univ of Med & Dentistry of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Bentley-Salick Medical Practice PC
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Univ of Cincinnati / Holmes Hosp
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Julio Arroyo
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Southwest Infectious Diseases Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Joseph C Gathe
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Wisconsin AIDS Research Consortium
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53203
Country
United States
Facility Name
Canadian HIV Trials Network
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
QEII Health Science Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Montreal Chest Institute
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Immunity Care and Research Inc
City
Santo Domingo
Country
Dominican Republic
Facility Name
Univ of Puerto Rico School of Med
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico Inc
City
San Juan
ZIP/Postal Code
009091711
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients

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