Full Text View
Tabular View
No Study Results Posted
Related Studies
Effectiveness of Treating HIV-Positive Patients With an HIV Vaccine (Remune)
This study is ongoing, but not recruiting participants.
First Received: March 21, 2000   Last Updated: June 23, 2005   History of Changes
Sponsored by: Agouron Pharmaceuticals
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00005002
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Lamivudine/Zidovudine
Biological: HIV-1 Immunogen
Drug: Nelfinavir mesylate
Phase III

MedlinePlus related topics: AIDS AIDS Medicines
Drug Information available for: Zidovudine Lamivudine Nelfinavir Nelfinavir Mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Double-Blind, Efficacy Study
Official Title: 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)

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

Estimated Enrollment: 688
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005002

Locations
United States, California
Agouron Pharmaceuticals Inc
San Diego, California, United States, 92121
Sponsors and Collaborators
Agouron Pharmaceuticals
  More Information

No publications provided

Study ID Numbers: B009, AG1661-202
Study First Received: March 21, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00005002     History of Changes
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
CD4 Lymphocyte Count
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
remune
Combivir

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Adjuvants, Immunologic
Zidovudine
Lamivudine
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Freund's Adjuvant
Nelfinavir
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Nelfinavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
HIV Protease Inhibitors
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on May 07, 2009