- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005002
Effectiveness of Treating HIV-Positive Patients With an HIV Vaccine (Remune)
June 23, 2005 updated by: Agouron Pharmaceuticals
A Randomized, Double-Blind, Adjuvant-Controlled, Multicenter Study to Compare the Virologic and Immunologic Effect of Highly Active Antiretroviral Therapy (HAART) Plus Remune Versus HAART Plus Incomplete Freund's Adjuvant (IFA) in Antiretroviral-Naive Patients Infected With Human Immunodeficiency Virus Type 1 (HIV-1)
The purpose of this study is to see if it is effective to add an HIV vaccine (Remune) to the anti-HIV drug combination of Combivir (zidovudine plus lamivudine) and nelfinavir.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
All patients begin HAART at study entry (Day 1).
Patients with a plasma HIV-1 RNA level less than or equal to 2,000 copies/ml at Week 8 are randomized to receive Remune or Incomplete Freund's Adjuvant (IFA) at Week 9. Patients who do not achieve a plasma HIV-1 RNA level of less than or equal to 2,000 copies/ml at Week 8 are not randomized and are terminated from the study.
These patients are eligible to receive funding for up to a 3-month supply of nelfinavir (Viracept) and Combivir.
Randomized patients receive Remune or IFA at Week 9 and approximately every 12 weeks thereafter until study completion (when the last patient reaches Week 48).
Patients are considered virologic failures if they (1) fail to achieve a virologic response by Week 48 or (2) after achieving a virologic response, have a virologic relapse.
Regardless of their previous response status, patients whose plasma HIV-1 RNA level increases to greater than 2,000 copies/ml while they are receiving protocol-specified HAART are eligible to receive salvage therapy and continue to receive Remune or IFA until study completion.
Study visits occur at screening, Day 1, Weeks 4, 8, 9, 12, and then every 4 weeks thereafter until the last patient reaches Week 48.
Patients who complete this study are eligible to participate in a rollover study.
Study Type
Interventional
Enrollment
688
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92121
- Agouron Pharmaceuticals Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV-positive.
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Have a viral load of at least 10,000 copies/ml.
- Have a CD4 count of at least 250 cells/mm3.
- Have never taken any anti-HIV drugs before.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
March 21, 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
August 1, 2001
More Information
Terms related to this study
Keywords
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
- Antimetabolites
- Protease Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Lamivudine
- Zidovudine
- Nelfinavir
- Lamivudine, zidovudine drug combination
Other Study ID Numbers
- B009
- AG1661-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Nelfinavir mesylate
-
Agouron PharmaceuticalsCompletedHIV Infections | Cytomegalovirus RetinitisUnited States
-
Agouron PharmaceuticalsCompletedHIV Infections | Mycobacterium Avium-Intracellulare InfectionUnited States
-
Agouron PharmaceuticalsCompleted
-
Agouron PharmaceuticalsCompletedHIV Infections | Sarcoma, KaposiUnited States
-
Agouron PharmaceuticalsCompleted
-
National Cancer Institute (NCI)Completed
-
Bristol-Myers SquibbTerminatedHIV InfectionsUnited States, Mexico, Canada, Puerto Rico, Thailand
-
Pharmacia and UpjohnCompletedHIV InfectionsUnited States
-
Merck Sharp & Dohme LLCCompletedHIV InfectionsUnited States