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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004998
Recruitment Status : Suspended
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: Lamivudine/Zidovudine Drug: Capravirine Drug: Nelfinavir mesylate Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
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
Study Start Date : November 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004998

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 Identifier: NCT00004998     History of Changes
Other Study ID Numbers: 286B
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 2001

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine, zidovudine drug combination
Anti-Retroviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors