Safety and Effectiveness of a New Anti-HIV Drug (AG1549) in Combination With Other Anti-HIV Drugs in HIV-Infected Patients

This study has suspended participant recruitment.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00004998
First received: March 21, 2000
Last updated: June 23, 2005
Last verified: March 2001
  Purpose

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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label Study of AG1549 in Combination With Other Antiretroviral Agents 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: 30
Study Start Date: November 1999
Detailed Description:

[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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004998

Locations
United States, Florida
Clin Research of West Florida
Clearwater, Florida, United States, 33765
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
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
Sponsors and Collaborators
Agouron Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004998     History of Changes
Other Study ID Numbers: 286B, AG1549-503
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
Reverse Transcriptase Inhibitors
Anti-HIV Agents
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
Anti-HIV Agents
Anti-Retroviral Agents
HIV Protease Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Protease Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014