Effectiveness of Treating HIV-Positive Patients With an HIV Vaccine (Remune)

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00005002
• Other study ID #: B009
• Secondary ID: AG1661-202
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 21, 2000
• Last updated: June 23, 2005

Study information

• Verified date: August 2001
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 688
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lamivudine/Zidovudine

Biological:
• HIV-1 Immunogen

Drug:
• Nelfinavir mesylate

Locations

Country	Name	City	State
United States	Agouron Pharmaceuticals Inc	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Agouron Pharmaceuticals

Country where clinical trial is conducted

United States,