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	Treatment or Intervention	Phase
HIV Infections	Drug: Lamivudine/Zidovudine  Drug: Capravirine  Drug: Nelfinavir mesylate	Phase II

Further Study Details: 

Expected Total Enrollment:  350

[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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

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

Study ID Numbers:  286C; AG1549-504
Record last reviewed:  March 2001
Last Updated:  October 13, 2004
Record first received:  March 21, 2000
ClinicalTrials.gov Identifier:  NCT00004999
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08