Clinical trial NCT00004999: 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
Overall status: SUSPENDED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Zidovudine
HIV Protease Inhibitors
Lamivudine
Disease Progression
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Nelfinavir
Combivir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

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