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

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

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.

Study Overview

• Status: Suspended
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Nelfinavir mesylate; Drug: Lamivudine/Zidovudine; Drug: Capravirine

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.

• Study Type: Interventional
• Enrollment: 350
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Canadian HIV Trials Network
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • QEII Health Science Centre
  • Ontario
    • Toronto, Ontario, Canada
      • Sunnybrook Health Science Centre
  • Quebec
    • Montreal, Quebec, Canada
      • Montreal Chest Institute
• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Immunity Care and Research Inc
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Univ of Puerto Rico School of Med
  • San Juan, Puerto Rico, 009091711
    • Clinical Research Puerto Rico Inc
• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Arizona Clinical Research Ctr Inc
  • California
    • Los Angeles, California, United States, 90033
      • Univ of Southern California
    • Oakland, California, United States, 946021018
      • Highland Gen Hosp / San Francisco Gen Hosp
    • Palm Springs, California, United States, 92262
      • ViRx Inc
    • San Francisco, California, United States, 94114
      • Research & Treatment at the California Pacific Med Ctr
    • Torrance, California, United States, 90502
      • Harbor - UCLA Med Ctr
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • IDC Research Initiative
    • Bradenton, Florida, United States, 34205
      • Bach and Godofsky
    • Fort Lauderdale, Florida, United States, 33306
      • Community Health Care
    • Jacksonville, Florida, United States, 32209
      • Univ of Florida
    • Miami, Florida, United States, 33136
      • Univ of Miami School of Medicine
    • Miami, Florida, United States, 33142
      • Specialty Med Care Ctrs of South Florida Inc
    • Miami, Florida, United States, 33139
      • South Shore Hosp
    • Orlando, Florida, United States, 32805
      • Orange County Health Dept
    • Palm Springs, Florida, United States, 33461
      • Larry Bush
    • Sarasota, Florida, United States, 34239
      • Infectious Diseases Associates
    • Tampa, Florida, United States, 33614
      • Infectious Disease Research Institute
    • Vero Beach, Florida, United States, 32960
      • Treasure Coast Infectious Disease Consultants
    • Winter Haven, Florida, United States, 33881
      • Polk County Health Dept
  • Idaho
    • Boise, Idaho, United States, 83704
      • Sky Blue
  • Illinois
    • Chicago, Illinois, United States, 60612
      • The CORE Ctr
    • Chicago, Illinois, United States, 60611
      • Northwestern Univ Med Ctr
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Univ Infectious Disease Research Clinic
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Univ of Iowa
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Univ of Kansas School of Medicine
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville / ID Division
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • HIV Outpatient Clinics / LA State Univ Med Ctr
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Fenway Community Health Ctr
    • New Bedford, Massachusetts, United States, 02745
      • Hawthorne Med Associates / PAACA
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Kansas City AIDS Research Consortium
  • Nebraska
    • Omaha, Nebraska, United States, 681985400
      • Univ of Nebraska Medical CTR
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08034
      • Paul Alessi
    • East Orange, New Jersey, United States, 07018
      • VAMC New Jersey Healthcare System
    • Hoboken, New Jersey, United States, 07030
      • St Mary's Hosp Family Treatment Ctr
    • Newark, New Jersey, United States, 07103
      • Univ of Med & Dentistry of New Jersey
  • New York
    • New York, New York, United States, 10003
      • Bentley-Salick Medical Practice PC
    • Rochester, New York, United States, 14642
      • Univ of Rochester Med Ctr
  • Ohio
    • Cincinnati, Ohio, United States, 452670405
      • Univ of Cincinnati / Holmes Hosp
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Med Univ of South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Julio Arroyo
  • Texas
    • Dallas, Texas, United States, 75246
      • Southwest Infectious Diseases Associates
    • Galveston, Texas, United States, 77555
      • Univ TX Galveston Med Branch
    • Houston, Texas, United States, 77009
      • Thomas Street Clinic
    • Houston, Texas, United States, 77004
      • Joseph C Gathe
  • Virginia
    • Hampton, Virginia, United States, 23666
      • Hampton Roads Med Specialists
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53203
      • Wisconsin AIDS Research Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: Double

Collaborators and Investigators

• Sponsor: Agouron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: August 1, 1999

Study Registration Dates

• First Submitted: March 21, 2000
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: March 1, 2001

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Lamivudine; Viral Load; Disease Progression; Zidovudine; HIV Protease Inhibitors; Nelfinavir; Combivir
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Lamivudine; Zidovudine; Nelfinavir; Lamivudine, zidovudine drug combination; Capravirine
• Other Study ID Numbers: 286C; AG1549-504