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Completed Phase 3 Interventional

Effectiveness of Giving an HIV Vaccine (Remune) to HIV-Positive Patients Receiving an Anti-HIV Drug Combination

ClinicalTrials.gov ID: NCT00005758

Public ClinicalTrials.gov record NCT00005758. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 5:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Effect of Immunization With an HIV Immunogen on the Time to Virologic Relapse in Individuals Receiving Potent, Suppressive Antiretroviral Therapies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to look at the effects of the HIV vaccine Remune on viral load (level of HIV in the blood) and on the way the immune system responds to HIV. This study will also try to see if the effects of the vaccine are different in patients entering the study with a viral load below 50 copies/ml compared to those who have a viral load from 50 to 500 copies/ml. (This study is currently being redesigned and the purpose may be revised.) Treatment with anti-HIV drugs does not always keep HIV viral load undetectable (so low that it cannot be measured). This study originally added an HIV vaccine called Remune to treat patients. Remune was thought to reduce viral load and improve immune responses. However, new information suggests that Remune may not be as effective as was first believed. The study has been changed to follow people already in the study and to let people enroll only if they participate in the substudy. The substudy will look at the effect of another HIV vaccine, vCP1452, on the immune response and how it works in combination with Remune. Information about the safety of these vaccines in HIV-positive patients will be gathered.

Study identification

NCT ID
NCT00005758
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
472 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
14 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Aug 31, 2005
Last update posted
Oct 31, 2021

Ends 2005

United States locations

U.S. sites
17
U.S. states
10
U.S. cities
13
Facility City State ZIP Site status
USC CRS Los Angeles California 900331079
Stanford CRS Palo Alto California 943055107
Ucsf Aids Crs San Francisco California 941102859
Univ. of Miami AIDS CRS Miami Florida 331361013
Univ. of Hawaii at Manoa, Leahi Hosp. Honolulu Hawaii 96816
Johns Hopkins Adult AIDS CRS Baltimore Maryland 21287
Massachusetts General Hospital ACTG CRS Boston Massachusetts 02114
Beth Israel Deaconess Med. Ctr., ACTG CRS Boston Massachusetts 02215
Brigham and Women's Hosp. ACTG CRS Boston Massachusetts 02215
Bmc Actg Crs Boston Massachusetts
Beth Israel Med. Ctr., ACTU New York New York 10003
NY Univ. HIV/AIDS CRS New York New York 10016
Univ. of Rochester ACTG CRS Rochester New York 14642
Unc Aids Crs Chapel Hill North Carolina 275997215
Case CRS Cleveland Ohio 44106
Hosp. of the Univ. of Pennsylvania CRS Philadelphia Pennsylvania 19104
Vanderbilt Therapeutics CRS Nashville Tennessee 37203

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00005758, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 31, 2021 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00005758 live on ClinicalTrials.gov.

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