The impact of therapeutic Human Immunodeficiency Virus (HIV) vaccination followed by antiretroviral therapy in patients with prolonged viral suppression

A pilot study to determine the impact of therapeutic Human Immunodeficiency Virus (HIV) vaccination followed by a scheduled interruption of antiretroviral therapy on HIV-specific immune function by a scheduled virologic rebound in patients with prolonged viral suppression

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87061665

Enrollment

Registered

2005-11-16

Start date

2001-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus (HIV) Infections and Infestations Human immunodeficiency virus (HIV)

Interventions

1. Remune™ (1 ml intramuscular [im]) at weeks 0, 12, and 20 2. ALVAC (1 ml im) at weeks 8, 12, 16, and 20 Trial details received 12 September 2005

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. HIV positive CD4 greater than 500 2. Age 18 years and older, either sex 3. CD4 nadir greater than 250 4. Viral load less than 50 for greater than 2 years 5. Receiving a Protease Inhibitor (PI) or Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)

Exclusion criteria

Exclusion criteria: 1. Patients with previous Acquired Immunodeficiency Syndrome (AIDS) defining opportunistic infections, previous cancer chemotherapy or other system immunosuppressive therapy 2. Patients with concurrent infections with hepatitis C or hepatitis B or any other acute illness

Design outcomes

Primary

Measure	Time frame
Time to virologic rebound.	—

Secondary

Measure	Time frame
1. To determine if, in patients with prolonged suppression of viral replication, therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in a delay in viral rebound to detectable levels (greater than 50 copies/ml) compared to a scheduled interruption of antiretroviral therapy without prior vaccination (vaccine placebo) 2. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in a delay in the rebound of plasma HIV Ribonucleic Acid (RNA) level to 10,000 copies/ml following discontinuation of antiretroviral therapy compared to a scheduled interruption of antiretroviral therapy without prior vaccination 3. To determine if therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in a delay in the rebound of plasma HIV RNA level to 10,000 copies/ml following discontinuation of antiretroviral therapy compared to a scheduled interruption of antiretroviral therapy without prior vaccination 4. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in a decrease in the viral set-point (steady state plasma HIV RNA level) compared to scheduled interruption of antiretroviral therapy without prior vaccination 5. To determine if therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in a decrease in the viral set-point (steady state plasma HIV RNA level) compared to scheduled interruption of antiretroviral therapy without prior vaccination 6. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in a decrease in the magnitude of viral load rebound compared to scheduled interruption of antiretroviral therapy without prior vaccination 7. To determine if therap	—

Measure

Time frame

1. To determine if, in patients with prolonged suppression of viral replication, therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in a delay in viral rebound to detectable levels (greater than 50 copies/ml) compared to a scheduled interruption of antiretroviral therapy without prior vaccination (vaccine placebo) 2. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in a delay in the rebound of plasma HIV Ribonucleic Acid (RNA) level to 10,000 copies/ml following discontinuation of antiretroviral therapy compared to a scheduled interruption of antiretroviral therapy without prior vaccination 3. To determine if therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in a delay in the rebound of plasma HIV RNA level to 10,000 copies/ml following discontinuation of antiretroviral therapy compared to a scheduled interruption of antiretroviral therapy without prior vaccination 4. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in a decrease in the viral set-point (steady state plasma HIV RNA level) compared to scheduled interruption of antiretroviral therapy without prior vaccination 5. To determine if therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in a decrease in the viral set-point (steady state plasma HIV RNA level) compared to scheduled interruption of antiretroviral therapy without prior vaccination 6. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in a decrease in the magnitude of viral load rebound compared to scheduled interruption of antiretroviral therapy without prior vaccination 7. To determine if therap

—

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026