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

NCT ID: NCT00004985

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Brief Summary

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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.

Detailed Description

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\[Note: As of 2/28/2001, due to toxicity studies and concern for safety, changes in the methodology were implemented and patients need to sign new informed consents. The study is unblinded. Group 1 receives AG1549; Group 2 receives an AG1549 placebo. Patients who are taking capravirine and who currently have viral loads below 400 copies/ml may continue to take capravirine at 1400 mg twice daily. Capravirine will be discontinued in patients with viral loads greater than 400 copies/ml at their last visit and they will be switched to new therapies or continue with their background therapies as deemed appropriate by the investigators.\] 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.

Conditions

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HIV Infections

Keywords

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HIV-1 Drug Therapy, Combination HIV Protease Inhibitors RNA, Viral Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Nelfinavir

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Capravirine

Intervention Type DRUG

Nelfinavir mesylate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agouron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Phoenix Body Positive

Phoenix, Arizona, United States

Site Status

Pacific Oaks Med Group

Beverly Hills, California, United States

Site Status

First Choice Medical

Palm Springs, California, United States

Site Status

Apogee Med Group

San Diego, California, United States

Site Status

Saint Francis Mem Hosp / HIV Care Unit

San Francisco, California, United States

Site Status

Kaiser Foundation Hospital

San Francisco, California, United States

Site Status

Harbor - UCLA Med Ctr

Torrance, California, United States

Site Status

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

Site Status

Bach and Godofsky

Bradenton, Florida, United States

Site Status

Clin Research of West Florida

Clearwater, Florida, United States

Site Status

Community Health Care

Fort Lauderdale, Florida, United States

Site Status

Therafirst Med Ctr

Fort Lauderdale, Florida, United States

Site Status

South Shore Hosp

Miami, Florida, United States

Site Status

Immunity Care and Research Inc

Miami Beach, Florida, United States

Site Status

Orange County Health Dept

Orlando, Florida, United States

Site Status

Infectious Diseases Associates

Sarasota, Florida, United States

Site Status

Hillsborough County Health Dept

Tampa, Florida, United States

Site Status

Treasure Coast Infectious Disease Consultants

Vero Beach, Florida, United States

Site Status

Polk County Health Dept

Winter Haven, Florida, United States

Site Status

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Site Status

Braude Mermin Spivey MD PC

Atlanta, Georgia, United States

Site Status

Massachusetts Gen Hosp

Boston, Massachusetts, United States

Site Status

Fenway Community Health Ctr

Boston, Massachusetts, United States

Site Status

VAMC New Jersey Healthcare System

East Orange, New Jersey, United States

Site Status

Jersey Shore Med Ctr

Neptune City, New Jersey, United States

Site Status

Infectious Disease Assoc of Central Jersey

Somerville, New Jersey, United States

Site Status

Biomedical Research Alliance of New York

Jamaica, New York, United States

Site Status

North Shore Univ Hosp

Manhasset, New York, United States

Site Status

Liberty Medical

New York, New York, United States

Site Status

Mount Sinai Med Ctr

New York, New York, United States

Site Status

Central Texas Clinical Research

Austin, Texas, United States

Site Status

Univ TX Galveston Med Branch

Galveston, Texas, United States

Site Status

Infectious Disease Physicians Inc

Annandale, Virginia, United States

Site Status

Clinical Research Puerto Rico Inc

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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AG1549-509

Identifier Type: -

Identifier Source: secondary_id

286D

Identifier Type: -

Identifier Source: org_study_id