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NCT00004999 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT00004999
Other study ID # 286C
Secondary ID AG1549-504
Status Suspended
Phase Phase 2
First received March 21, 2000
Last updated June 23, 2005
Start date August 1999

Study information
Verified date March 2001
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Suspended
Enrollment 350
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lamivudine/Zidovudine

• Capravirine

• Nelfinavir mesylate

Locations
Country Name City State
Canada QEII Health Science Centre Halifax Nova Scotia
Canada Montreal Chest Institute Montreal Quebec
Canada Sunnybrook Health Science Centre Toronto Ontario
Canada Canadian HIV Trials Network Vancouver British Columbia
Dominican Republic Immunity Care and Research Inc Santo Domingo
Puerto Rico Univ of Puerto Rico School of Med Rio Piedras
Puerto Rico Clinical Research Puerto Rico Inc San Juan
United States IDC Research Initiative Altamonte Springs Florida
United States Sky Blue Boise Idaho
United States Fenway Community Health Ctr Boston Massachusetts
United States Bach and Godofsky Bradenton Florida
United States Med Univ of South Carolina Charleston South Carolina
United States Paul Alessi Cherry Hill New Jersey
United States Northwestern Univ Med Ctr Chicago Illinois
United States The CORE Ctr Chicago Illinois
United States Univ of Cincinnati / Holmes Hosp Cincinnati Ohio
United States Southwest Infectious Diseases Associates Dallas Texas
United States VAMC New Jersey Healthcare System East Orange New Jersey
United States Community Health Care Fort Lauderdale Florida
United States Univ TX Galveston Med Branch Galveston Texas
United States Hampton Roads Med Specialists Hampton Virginia
United States St Mary's Hosp Family Treatment Ctr Hoboken New Jersey
United States Joseph C Gathe Houston Texas
United States Thomas Street Clinic Houston Texas
United States Indiana Univ Infectious Disease Research Clinic Indianapolis Indiana
United States Univ of Iowa Iowa City Iowa
United States Univ of Florida Jacksonville Florida
United States Kansas City AIDS Research Consortium Kansas City Missouri
United States Univ of Southern California Los Angeles California
United States University of Louisville / ID Division Louisville Kentucky
United States South Shore Hosp Miami Florida
United States Specialty Med Care Ctrs of South Florida Inc Miami Florida
United States Univ of Miami School of Medicine Miami Florida
United States Wisconsin AIDS Research Consortium Milwaukee Wisconsin
United States Hawthorne Med Associates / PAACA New Bedford Massachusetts
United States HIV Outpatient Clinics / LA State Univ Med Ctr New Orleans Louisiana
United States Bentley-Salick Medical Practice PC New York New York
United States Univ of Med & Dentistry of New Jersey Newark New Jersey
United States Highland Gen Hosp / San Francisco Gen Hosp Oakland California
United States Univ of Nebraska Medical Ctr Omaha Nebraska
United States Orange County Health Dept Orlando Florida
United States Larry Bush Palm Springs Florida
United States ViRx Inc Palm Springs California
United States Univ of Rochester Med Ctr Rochester New York
United States Research & Treatment at the California Pacific Med Ctr San Francisco California
United States Infectious Diseases Associates Sarasota Florida
United States Infectious Disease Research Institute Tampa Florida
United States Harbor - UCLA Med Ctr Torrance California
United States Arizona Clinical Research Ctr Inc Tucson Arizona
United States Treasure Coast Infectious Disease Consultants Vero Beach Florida
United States Julio Arroyo West Columbia South Carolina
United States Univ of Kansas School of Medicine Wichita Kansas
United States Polk County Health Dept Winter Haven Florida

Sponsors (1)
Lead Sponsor Collaborator
Agouron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Dominican Republic,  Puerto Rico, 

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