Combination Treatment Using Capravirine (AG1549), Nelfinavir, and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Patients Who Failed Initial Combination Therapy

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00004985
First received: March 15, 2000
Last updated: June 23, 2005
Last verified: March 2001
  Purpose

The purpose of this study is to look at the effectiveness of an anti-HIV drug combination that adds capravirine in patients who have failed their first drug combination treatment.


Condition Intervention Phase
HIV Infections
Drug: Capravirine
Drug: Nelfinavir mesylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Phase II, Single-Blind, Randomized, Placebo-Controlled Study of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Subjects Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 75
Study Start Date: January 2000
Detailed Description:

[Note: As of 2/28/2001, due to toxicity studies and concern for safety, changes in the methodology were implemented and patients need to sign new informed consents. The study is unblinded. Group 1 receives AG1549; Group 2 receives an AG1549 placebo. Patients who are taking capravirine and who currently have viral loads below 400 copies/ml may continue to take capravirine at 1400 mg twice daily. Capravirine will be discontinued in patients with viral loads greater than 400 copies/ml at their last visit and they will be switched to new therapies or continue with their background therapies as deemed appropriate by the investigators.] Both groups also receive nelfinavir mesylate and 2 NRTIs. All patients receive the same dose of nelfinavir mesylate. The NRTIs are selected at the investigator's discretion provided the patient has not previously received the chosen NRTIs. Patients have regular physical examinations. Blood samples are collected regularly and at 1 month post-treatment to determine plasma HIV RNA, pharmacokinetics, and CD4 and CD8 counts. Patients who complete 24 weeks of treatment will have the option to continue treatment for an additional 24 weeks or end participation.

  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 for this trial if they:

  • Are HIV-positive.
  • Have a CD4 cell count more than 50/mm3.
  • Are at least 18 years old.
  • Have adequate blood, kidney, and liver functions.
  • Are currently taking an anti-HIV drug combination of an NNRTI plus 1 or more NRTIs for more than 28 days and are failing that combination.

Exclusion Criteria

Patients will not be eligible for this trial if they:

  • Have had any protease inhibitor or capravirine treatment.
  • Have been given any drug that interferes with their immune system or with the study drugs within 28 days of study entry.
  • Have had radiation therapy 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: NCT00004985

  Hide Study Locations
Locations
United States, Arizona
Phoenix Body Positive
Phoenix, Arizona, United States, 85016
United States, California
Pacific Oaks Med Group
Beverly Hills, California, United States, 90211
First Choice Medical
Palm Springs, California, United States, 92262
Apogee Med Group
San Diego, California, United States, 92101
Kaiser Foundation Hospital
San Francisco, California, United States, 94118
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, United States, 94109
Harbor - UCLA Med Ctr
Torrance, California, United States, 90502
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, Florida
Bach and Godofsky
Bradenton, Florida, United States, 34205
Clin Research of West Florida
Clearwater, Florida, United States, 33765
Community Health Care
Fort Lauderdale, Florida, United States, 33306
Therafirst Med Ctr
Fort Lauderdale, Florida, United States, 33308
South Shore Hosp
Miami, Florida, United States, 33139
Immunity Care and Research Inc
Miami Beach, Florida, United States, 33139
Orange County Health Dept
Orlando, Florida, United States, 32805
Infectious Diseases Associates
Sarasota, Florida, United States, 34239
Hillsborough County Health Dept
Tampa, Florida, United States, 33602
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
Polk County Health Dept
Winter Haven, Florida, United States, 33881
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Braude Mermin Spivey MD PC
Atlanta, Georgia, United States, 30309
United States, Massachusetts
Fenway Community Health Ctr
Boston, Massachusetts, United States, 02115
Massachusetts Gen Hosp
Boston, Massachusetts, United States, 02114
United States, New Jersey
VAMC New Jersey Healthcare System
East Orange, New Jersey, United States, 07018
Jersey Shore Med Ctr
Neptune, New Jersey, United States, 07753
Infectious Disease Assoc of Central Jersey
Somerville, New Jersey, United States, 08876
United States, New York
Biomedical Research Alliance of New York
Jamaica, New York, United States, 11432
North Shore Univ Hosp
Manhasset, New York, United States, 11030
Liberty Medical
New York, New York, United States, 10014
Mount Sinai Med Ctr
New York, New York, United States, 10029
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77555
United States, Virginia
Infectious Disease Physicians Inc
Annandale, Virginia, United States, 22203
Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, Puerto Rico, 009091711
Sponsors and Collaborators
Agouron Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004985     History of Changes
Other Study ID Numbers: 286D, AG1549-509
Study First Received: March 15, 2000
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Nelfinavir

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
HIV Protease Inhibitors
Nelfinavir
Reverse Transcriptase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 15, 2014