Clinical trial NCT00329251: Study of the Influence of Vaccination in HIV Viral Load and Immunologic Responses Against HIV
Official title: Study of the Influence of Immunological Repeated Stimuli With Commercial Vaccines Over the Viral Load (VL), Resistance Development and Specific Immunological Response Against HIV in Early Stage HIV Patients With Undetectable VL After HAART
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: HIV
Viral load
Vaccines
Immunotherapy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2006-05-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether an immunization schedule is beneficial to HIV-infected patients with CD4 recount over 500 cells/mm3 and undetectable viral load.

Detailed description: As HIV-infected patients are considered immunocompromised, it is generally recommended that they have to receipt appropriate vaccines. However data are conflicting concerning potential harmful effects following the administration of commercial vaccines in HIV-infected patients. Transient increases ("blips") in the viral load have been described associated with a single dose of vaccine, with the potential risk of developing resistance to HAART. On the other hand, there has been described that patients with blips can have an increase in HIV-specific immune responses, which may help to improve the viral control.

Comparison: We have performed a clinical trial to evaluate the effect of a vaccination program in successfully treated HIV-infected adults on HAART compared to placebo.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Asymptomatic HIV infection
* CD4\>500/mm3 \>6 months prior to inclusion
* CD4 nadir \>300/mm3
* Being under HAART \> 1 year prior to inclusion
* Viral load\<200 copies/mL \> 6 months prior to inclusion
* Viral load previous to treatment \>5000 copies/mL
* Informed consent

Exclusion Criteria:

* Pregnant women
* Basal creatinine \>2.5 mg/dL
* Allergy to either a vaccine or a ingredient of it
* Chronic hepatitis B
* GOT/GPT \> 250 IU/L

Primary outcomes:
measure: Times viral load increases over 20.000 copies/mL.
Secondary outcomes:
measure: Development of resistance to antiretroviral therapy during the 18 months of the study
measure: Appearance of specific CD4 proliferative responses against HIV during the 18 months of the study
measure: Appearance of specific cytotoxic responses against HIV during the 18 months of the study
measure: Number of patients under 5000 copies/mL after 6 months of stopping HAART
measure: Development of symptoms C during the 18 months of the study
measure: Deaths during the 18 months of the study
measure: Toxicity during the 18 months of the study
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Department of Infectious Diseases, Hospital Clínic, C/Villarroel 170
Study officials:
affiliation: Hospital Clínic of Barcelona
name: José Mª Gatell, MD
role: STUDY_CHAIR
affiliation: Hospital Clínic of Barcelona
name: José Mª Miró, MD
role: STUDY_CHAIR
affiliation: Hospital Clínic of Barcelona
name: José Mª Bayas, MD
role: STUDY_CHAIR
References:
citation: Yek C, Gianella S, Plana M, Castro P, Scheffler K, Garcia F, Massanella M, Smith DM. Standard vaccines increase HIV-1 transcription during antiretroviral therapy. AIDS. 2016 Sep 24;30(15):2289-98. doi: 10.1097/QAD.0000000000001201.
citation: Castro P, Torres B, Lopez A, Gonzalez R, Vilella A, Nicolas JM, Gallart T, Pumarola T, Sanchez M, Leal M, Vallejo A, Bayas JM, Gatell JM, Plana M, Garcia F. Effects of different antigenic stimuli on thymic function and interleukin-7/CD127 system in patients with chronic HIV infection. J Acquir Immune Defic Syndr. 2014 Aug 15;66(5):466-72. doi: 10.1097/QAI.0000000000000207.
citation: Castro P, Plana M, Gonzalez R, Lopez A, Vilella A, Nicolas JM, Gallart T, Pumarola T, Bayas JM, Gatell JM, Garcia F. Influence of episodes of intermittent viremia ("blips") on immune responses and viral load rebound in successfully treated HIV-infected patients. AIDS Res Hum Retroviruses. 2013 Jan;29(1):68-76. doi: 10.1089/AID.2012.0145. Epub 2012 Dec 16.