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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00004999
First received: March 21, 2000
Last updated: June 23, 2005
Last verified: March 2001
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Lamivudine/Zidovudine
Drug: Capravirine
Drug: Nelfinavir mesylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 350
Study Start Date: August 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004999

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

No publications provided

ClinicalTrials.gov Identifier: NCT00004999     History of Changes
Other Study ID Numbers: 286C, AG1549-504
Study First Received: March 21, 2000
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Zidovudine
HIV Protease Inhibitors
Lamivudine
Disease Progression
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Nelfinavir
Combivir

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Lamivudine
Lamivudine, zidovudine drug combination
Nelfinavir
Reverse Transcriptase Inhibitors
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014