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Sponsored by: |
Agouron Pharmaceuticals |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00004998 |
The purpose of this study is to see if two different doses of AG1549 plus other anti-HIV drugs are safe and effective in 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, Safety Study |
Official Title: | A Phase II, Open-Label Study of AG1549 in Combination With Other Antiretroviral Agents in Treatment-Naive HIV-Infected Patients |
Estimated Enrollment: | 30 |
Study Start Date: | November 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 one of two doses of AG1549 plus Viracept (nelfinavir) plus Combivir (zidovudine/lamivudine). Patients remain on their assigned therapy for 48 weeks, with a follow-up visit at 28 to 35 days after the last dose of study medication. Blood samples are taken regularly to quantify HIV-1 RNA, CD4 and CD8 counts, peripheral blood mononuclear cells (PBMC), AG1549, Viracept, and M8 plasma concentrations. Physical exams, safety assessments, and other tests are also done throughout the study. On Day 8 and at the end of Week 48, pharmacokinetic samples are collected at 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, and 12.0 hours postdose. At the end of Weeks 4, 8, 16, 24, and 36, pharmacokinetic samples are taken prior to dosing and between 2 to 4 hours post-dose.
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:
United States, Florida | |
Community Health Care | |
Fort Lauderdale, Florida, United States, 33306 | |
South Shore Hosp | |
Miami, Florida, United States, 33139 | |
Infectious Diseases Associates | |
Sarasota, Florida, United States, 34239 | |
Clin Research of West Florida | |
Clearwater, Florida, United States, 33765 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Massachusetts | |
Beth Israel Deaconess Med Ctr | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Catholic Med Ctr | |
Jamaica, New York, United States, 11432 | |
Liberty Medical | |
New York, New York, United States, 10014 | |
United States, Pennsylvania | |
Anderson Clinical Research | |
Pittsburgh, Pennsylvania, United States, 15221 | |
Dominican Republic | |
Immunity Care and Research Inc | |
Santo Domingo, Dominican Republic |
Study ID Numbers: | 286B, AG1549-503 |
Study First Received: | March 21, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004998 |
Health Authority: | United States: Food and Drug Administration |
Drug Therapy, Combination Zidovudine HIV Protease Inhibitors Lamivudine |
Reverse Transcriptase Inhibitors Anti-HIV Agents Nelfinavir Combivir |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Lamivudine Zidovudine Nelfinavir Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |