Phase 2 N=52 Randomized Triple-blind Treatment

Combination Vaccination Before HIV Treatment Interruption

HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT00212888 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group — 24.5; 13.5 days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Remune and ALVAC (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ottawa Hospital Research Institute
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group	24.5; 13.5	—
SECONDARY Time to Detectable Virus in the ALVAC Alone Group and the Placebo Group	23.0; 13.5	—
SECONDARY Time to Rebound of Plasma HIV RNA Level to 10,000 Copies/ml	30.0; 31.0; 24.5	—
SECONDARY Viral Set-point	4.4; 4.2; 4.5	—
SECONDARY Magnitude of Viral Rebound	4.8; 5.0; 5.0	—
SECONDARY HIV-specific Immune Function	—	—

Summary

The purpose of this study is to determine if vaccination before a structured treatment interruption (STI) is associated with an improvement in immune function, resulting in a delayed and reduced rebound in the amount of HIV virus in the blood.

Eligibility Criteria

Inclusion Criteria

Documented HIV infection (by serology)
HIV RNA level below 50 copies/ml for at least two years
Receiving at least 2 antiretroviral agents including at least 1 protease inhibitor or 1 non-nucleoside reverse transcriptase inhibitor at time of screening
Have CD4 counts above 500 cells/ul
Have CD4/CD8 ratio above 0.5
Have never had a CD4 count below 250
No previous AIDS-defining opportunistic infection
No previous cancer chemotherapy or other system immunosuppressive therapy (excluding brief courses [<= 1 month] of prednisone or its equivalent)
Able to provide informed consent

Exclusion Criteria

Hepatitis B surface antigen positive
Hepatitis C antibody positive
AST, ALT, ALP, creatinine, urea above three times the normal upper limit
Blood abnormalities (hemoglobin lower than 100, white blood cell count [WBC] lower than 1500 or platelets lower than 100)
Allergies to components of Remune™ or ALVAC
Contraindications to vaccine components
Pregnancy or breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00212888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.