|
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: | 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 |
| 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
Show 53 Study Locations
More Information
| 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 |
|
Drug Therapy, Combination Zidovudine HIV Protease Inhibitors Lamivudine Disease Progression |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Nelfinavir Combivir |
|
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 |