|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Agouron Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00004999 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Efficacy Study |
| 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 |
| Estimated Enrollment: | 350 |
| Study Start Date: | August 1999 |
[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 |
Inclusion Criteria
Patients may be eligible if they:
Exclusion Criteria
Patients will not be eligible if they:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Arizona Clinical Research Ctr Inc | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Highland Gen Hosp / San Francisco Gen Hosp | |
| Oakland, California, United States, 946021018 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| Research & Treatment at the California Pacific Med Ctr | |
| San Francisco, California, United States, 94114 | |
| Univ of Southern California | |
| Los Angeles, California, United States, 90033 | |
| ViRx Inc | |
| Palm Springs, California, United States, 92262 | |
| United States, Florida | |
| South Shore Hosp | |
| Miami, Florida, United States, 33139 | |
| Treasure Coast Infectious Disease Consultants | |
| Vero Beach, Florida, United States, 32960 | |
| Infectious Disease Research Institute | |
| Tampa, Florida, United States, 33614 | |
| Bach and Godofsky | |
| Bradenton, Florida, United States, 34205 | |
| Specialty Med Care Ctrs of South Florida Inc | |
| Miami, Florida, United States, 33142 | |
| Community Health Care | |
| Fort Lauderdale, Florida, United States, 33306 | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| Orange County Health Dept | |
| Orlando, Florida, United States, 32805 | |
| Infectious Diseases Associates | |
| Sarasota, Florida, United States, 34239 | |
| Polk County Health Dept | |
| Winter Haven, Florida, United States, 33881 | |
| Larry Bush | |
| Palm Springs, Florida, United States, 33461 | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Univ of Florida | |
| Jacksonville, Florida, United States, 32209 | |
| 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 | |
| VAMC New Jersey Healthcare System | |
| East Orange, New Jersey, United States, 07018 | |
| Paul Alessi | |
| Cherry Hill, New Jersey, United States, 08034 | |
| 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 | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 14642 | |
| Bentley-Salick Medical Practice PC | |
| New York, New York, United States, 10003 | |
| United States, Ohio | |
| Univ of Cincinnati / Holmes Hosp | |
| Cincinnati, Ohio, United States, 452670405 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| Med Univ of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77555 | |
| Thomas Street Clinic | |
| Houston, Texas, United States, 77009 | |
| Joseph C Gathe | |
| Houston, Texas, United States, 77004 | |
| Southwest Infectious Diseases Associates | |
| Dallas, Texas, United States, 75246 | |
| 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 | |
| Clinical Research Puerto Rico Inc | |
| San Juan, Puerto Rico, 009091711 | |
| Univ of Puerto Rico School of Med | |
| Rio Piedras, Puerto Rico, 00935 | |
More Information
| Study ID Numbers: | 286C, AG1549-504 |
| Study First Received: | March 21, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004999 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Zidovudine HIV Protease Inhibitors Lamivudine Disease Progression |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Nelfinavir Combivir |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Nelfinavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |