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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005001
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
The purpose of this study is to see if giving HIV-positive patients an HIV vaccine plus anti-HIV drugs can help lower HIV levels in the blood (viral load).

Condition or disease Intervention/treatment Phase
HIV Infections Biological: HIV-1 Immunogen Phase 2

Detailed Description:
At the time of study entry, all patients are receiving a HAART regimen consisting of three drugs from at least two classes of antiretroviral drugs. Upon entering the study, patients receive Remune or IFA at Weeks 0, 12, and 24. Patients remain on study for 40 weeks. Patients who have received three injections of Remune or IFA and whose plasma HIV-1 RNA level is less than 50 copies/ml at Week 26 discontinue HAART at Week 28. (If the patient has a plasma HIV-1 RNA level at or above 50 copies/ml at Week 26, he/she must have a measurement below 50 copies/ml at Week 27 to proceed with HAART discontinuation at Week 28. If by Week 27 the patient does not have a plasma HIV-1 RNA level below 50 copies/ml, the patient does not discontinue HAART but remains on study and has study visits at Weeks 34 and 40.) Patients who discontinue HAART have their plasma HIV-1 RNA levels measured on the day HAART is discontinued and at Days 3, 5, 7, 10, 14, 21, 28, 35, and 42 after discontinuation. Patients with a plasma HIV-1 RNA level of at least 5,000 copies/ml at Week 34 restart HAART at that time. (Patients whose plasma HIV-1 RNA level reaches greater than or equal to 100,000 copies/ml on two occasions before Week 34 have the option of restarting HAART immediately.) Patients whose plasma HIV-1 RNA level is less than 5,000 copies/ml at Week 34 do not restart HAART unless their level increases to at least 5,000 copies/ml. Patients who discontinue HAART are monitored intensively for the duration of the study. Patients have 27 visits if they stay on study until completion at Week 40.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Masking: Double
Primary Purpose: Treatment
Official Title: A Pilot, Phase II, Double-Blind Study to Assess the Virologic Effect of Remune Versus Incomplete Freund's Adjuvant (IFA) in Patients Who Are Infected With Human Immunodeficiency Virus Type I (HIV-1), Have a Plasma HIV-1 RNA Level Less Than 50 Copies/Ml, Are Receiving Highly Active Antiretroviral Therapy (HAART), and Who Subsequently Discontinue Their HAART Regimen

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Are receiving an anti-HIV drug combination that contains three drugs from at least two classes of anti-HIV drugs (such as protease inhibitors). Patients must have been receiving this drug combination for at least 6 months before study entry. Before beginning this drug combination, patients must have taken either no anti-HIV drugs or only one or two nucleoside analogues (NRTIs).
  • Had a viral load between 5,000 and 100,000 copies/ml before beginning their current anti-HIV therapy.
  • Have a viral load below 50 copies/ml while on their current anti-HIV therapy within 2 weeks before study entry.
  • Have a CD4 count greater than 350 cells/mm3 at the time of study entry.
  • Are at least 13 years old (consent of parent or guardian required if under 18).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005001

United States, California
Agouron Pharmaceuticals Inc
San Diego, California, United States, 92121
Sponsors and Collaborators
Agouron Pharmaceuticals Identifier: NCT00005001     History of Changes
Other Study ID Numbers: B008
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 2001

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
RNA, Viral
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases