Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients
This study has suspended participant recruitment.
Sponsor:
Agouron Pharmaceuticals
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00004999
First received: March 21, 2000
Last updated: June 23, 2005
Last verified: March 2001
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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 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
| 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 |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004999
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Hide Study LocationsLocations
| United States, Arizona | |
| Arizona Clinical Research Ctr Inc | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Univ of Southern California | |
| Los Angeles, California, United States, 90033 | |
| Highland Gen Hosp / San Francisco Gen Hosp | |
| Oakland, California, United States, 946021018 | |
| ViRx Inc | |
| Palm Springs, California, United States, 92262 | |
| Research & Treatment at the California Pacific Med Ctr | |
| San Francisco, California, United States, 94114 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| United States, Florida | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| Bach and Godofsky | |
| Bradenton, Florida, United States, 34205 | |
| Community Health Care | |
| Fort Lauderdale, Florida, United States, 33306 | |
| Univ of Florida | |
| Jacksonville, Florida, United States, 32209 | |
| Specialty Med Care Ctrs of South Florida Inc | |
| Miami, Florida, United States, 33142 | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| South Shore Hosp | |
| Miami, Florida, United States, 33139 | |
| Orange County Health Dept | |
| Orlando, Florida, United States, 32805 | |
| Larry Bush | |
| Palm Springs, Florida, United States, 33461 | |
| Infectious Diseases Associates | |
| Sarasota, Florida, United States, 34239 | |
| Infectious Disease Research Institute | |
| Tampa, Florida, United States, 33614 | |
| Treasure Coast Infectious Disease Consultants | |
| Vero Beach, Florida, United States, 32960 | |
| Polk County Health Dept | |
| Winter Haven, Florida, United States, 33881 | |
| 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 | |
| Paul Alessi | |
| Cherry Hill, New Jersey, United States, 08034 | |
| VAMC New Jersey Healthcare System | |
| East Orange, New Jersey, United States, 07018 | |
| 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 | |
| Bentley-Salick Medical Practice PC | |
| New York, New York, United States, 10003 | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 14642 | |
| United States, Ohio | |
| Univ of Cincinnati / Holmes Hosp | |
| Cincinnati, Ohio, United States, 452670405 | |
| United States, South Carolina | |
| Med Univ of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Texas | |
| Southwest Infectious Diseases Associates | |
| Dallas, Texas, United States, 75246 | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77555 | |
| Joseph C Gathe | |
| Houston, Texas, United States, 77004 | |
| Thomas Street Clinic | |
| Houston, Texas, United States, 77009 | |
| 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 | |
| Univ of Puerto Rico School of Med | |
| Rio Piedras, Puerto Rico, 00935 | |
| Clinical Research Puerto Rico Inc | |
| San Juan, Puerto Rico, 009091711 | |
Sponsors and Collaborators
Agouron Pharmaceuticals
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004999 History of Changes |
| Other Study ID Numbers: | 286C, AG1549-504 |
| Study First Received: | March 21, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Drug Therapy, Combination Zidovudine HIV Protease Inhibitors Lamivudine Disease Progression |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Nelfinavir Combivir |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Lamivudine Reverse Transcriptase Inhibitors |
Lamivudine, zidovudine drug combination Nelfinavir HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013