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

NCT ID: NCT00004999

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-08-31

Brief Summary

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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

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\[Note: As of 2/28/2001, due to toxicity studies and concerns for safety, sites were notified that they need to discontinue patients from the capravirine/placebo arms and continue patients with their background therapies or switch patients to new therapies, as deemed appropriate by the investigators.\] 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.

Conditions

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HIV Infections

Keywords

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Drug Therapy, Combination Zidovudine HIV Protease Inhibitors Lamivudine Disease Progression Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Nelfinavir Combivir

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lamivudine/Zidovudine

Intervention Type DRUG

Capravirine

Intervention Type DRUG

Nelfinavir mesylate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agouron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Arizona Clinical Research Ctr Inc

Tucson, Arizona, United States

Site Status

Univ of Southern California

Los Angeles, California, United States

Site Status

Highland Gen Hosp / San Francisco Gen Hosp

Oakland, California, United States

Site Status

ViRx Inc

Palm Springs, California, United States

Site Status

Research & Treatment at the California Pacific Med Ctr

San Francisco, California, United States

Site Status

Harbor - UCLA Med Ctr

Torrance, California, United States

Site Status

IDC Research Initiative

Altamonte Springs, Florida, United States

Site Status

Bach and Godofsky

Bradenton, Florida, United States

Site Status

Community Health Care

Fort Lauderdale, Florida, United States

Site Status

Univ of Florida

Jacksonville, Florida, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

South Shore Hosp

Miami, Florida, United States

Site Status

Specialty Med Care Ctrs of South Florida Inc

Miami, Florida, United States

Site Status

Orange County Health Dept

Orlando, Florida, United States

Site Status

Larry Bush

Palm Springs, Florida, United States

Site Status

Infectious Diseases Associates

Sarasota, Florida, United States

Site Status

Infectious Disease Research Institute

Tampa, Florida, United States

Site Status

Treasure Coast Infectious Disease Consultants

Vero Beach, Florida, United States

Site Status

Polk County Health Dept

Winter Haven, Florida, United States

Site Status

Sky Blue

Boise, Idaho, United States

Site Status

Northwestern Univ Med Ctr

Chicago, Illinois, United States

Site Status

The CORE Ctr

Chicago, Illinois, United States

Site Status

Indiana Univ Infectious Disease Research Clinic

Indianapolis, Indiana, United States

Site Status

Univ of Iowa

Iowa City, Iowa, United States

Site Status

Univ of Kansas School of Medicine

Wichita, Kansas, United States

Site Status

University of Louisville / ID Division

Louisville, Kentucky, United States

Site Status

HIV Outpatient Clinics / LA State Univ Med Ctr

New Orleans, Louisiana, United States

Site Status

Fenway Community Health Ctr

Boston, Massachusetts, United States

Site Status

Hawthorne Med Associates / PAACA

New Bedford, Massachusetts, United States

Site Status

Kansas City AIDS Research Consortium

Kansas City, Missouri, United States

Site Status

Univ of Nebraska Medical Ctr

Omaha, Nebraska, United States

Site Status

Paul Alessi

Cherry Hill, New Jersey, United States

Site Status

VAMC New Jersey Healthcare System

East Orange, New Jersey, United States

Site Status

St Mary's Hosp Family Treatment Ctr

Hoboken, New Jersey, United States

Site Status

Univ of Med & Dentistry of New Jersey

Newark, New Jersey, United States

Site Status

Bentley-Salick Medical Practice PC

New York, New York, United States

Site Status

Univ of Rochester Med Ctr

Rochester, New York, United States

Site Status

Univ of Cincinnati / Holmes Hosp

Cincinnati, Ohio, United States

Site Status

Med Univ of South Carolina

Charleston, South Carolina, United States

Site Status

Julio Arroyo

West Columbia, South Carolina, United States

Site Status

Southwest Infectious Diseases Associates

Dallas, Texas, United States

Site Status

Univ TX Galveston Med Branch

Galveston, Texas, United States

Site Status

Joseph C Gathe

Houston, Texas, United States

Site Status

Thomas Street Clinic

Houston, Texas, United States

Site Status

Hampton Roads Med Specialists

Hampton, Virginia, United States

Site Status

Wisconsin AIDS Research Consortium

Milwaukee, Wisconsin, United States

Site Status

Canadian HIV Trials Network

Vancouver, British Columbia, Canada

Site Status

QEII Health Science Centre

Halifax, Nova Scotia, Canada

Site Status

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Site Status

Montreal Chest Institute

Montreal, Quebec, Canada

Site Status

Immunity Care and Research Inc

Santo Domingo, , Dominican Republic

Site Status

Univ of Puerto Rico School of Med

Rio Piedras, , Puerto Rico

Site Status

Clinical Research Puerto Rico Inc

San Juan, , Puerto Rico

Site Status

Countries

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United States Canada Dominican Republic Puerto Rico

Other Identifiers

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AG1549-504

Identifier Type: -

Identifier Source: secondary_id

286C

Identifier Type: -

Identifier Source: org_study_id