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

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

688 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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HIV-1 Drug Therapy, Combination HIV Protease Inhibitors CD4 Lymphocyte Count Nelfinavir Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load remune Combivir

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lamivudine/Zidovudine

Intervention Type DRUG

HIV-1 Immunogen

Intervention Type BIOLOGICAL

Nelfinavir mesylate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Agouron Pharmaceuticals Inc

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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AG1661-202

Identifier Type: -

Identifier Source: secondary_id

B009