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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Nelfinavir mesylate; Drug: Capravirine

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.

• Study Type: Interventional
• Enrollment: 75
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Agouron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2000

Study Registration Dates

• First Submitted: March 15, 2000
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: March 1, 2001

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Anti-HIV Agents; HIV-1; RNA, Viral; Viral Load; HIV Protease Inhibitors; Nelfinavir
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Nelfinavir; Capravirine
• Other Study ID Numbers: 286D; AG1549-509