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Virus Therapy

Group 5: HIV infected adults and adolescents CD4 ≥ 200 cells/mm^3 with 2 doses for Ebola

Q: Is this clinical trial currently open for enrollment?

As per clinicaltrials.gov, the present trial is not in active recruitment. The data was initially shared on August 1st, 2017 and last revised by March 27th, 2023. Despite this particular study being closed for enrollment currently, there are alternative eight trials available for prospective participants.

Q: Is the clinical trial accepting individuals above the age of 30?

To be considered for this study, individuals must fall within the age range of 13 to 65. There are separate studies available for those under 18 (comprising four trials) and patients over 65 years old (consisting of seven distinct studies).

Q: Which specific criteria must individuals meet in order to be deemed suitable candidates for involvement in this clinical trial?

This clinical trial seeks to enroll 250 individuals aged between 13 and 65 who are currently afflicted with the <a href="https://www.withpower.com/clinical-trials/ebola">Ebola</a> virus. Eligible participants must meet specific requirements: they should be males or non-pregnant, non-breastfeeding females, within the age range of 13 to 65 at screening; under antiretroviral therapy with an undetectable viral load (&#x3C;40 c/ml); possess CD4 T cell counts ≥200 cells/mm3; provide written informed consent (or assent for adolescents) after thoroughly reviewing the consent form and having ample opportunity to discuss the study with a qualified investigator or delegate; exhibit no significant

Q: What is the risk level associated with administering 2 doses of treatment to patients in Group 5, which consists of HIV-infected adults and adolescents with a CD4 count greater than or equal to 200 cells/mm^3?

The safety assessment for Group 5, comprising <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-infected adults and adolescents with CD4 counts of at least 200 cells/mm^3 receiving two doses, is rated as a 2 on the scale. This rating indicates that while there are some existing safety data, no evidence supports efficacy in this Phase 2 trial context.

Phase 2

Waitlist Available

Led By Cecile Tremblay, MD

Research Sponsored by Cecile Tremblay

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

On antiretroviral therapy with an undetectable viral load (< 40 c/ml)

HIV-infected adult or adolescent male or non-pregnant, non-breastfeeding female, ages 13 to 65 (inclusive) at the time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the number of vaccine related sae's from signing the consent form to day 365 will be recorded and summarized.

Awards & highlights

Study Summary

"This trial is testing an Ebola virus vaccine in people with HIV. It will be conducted at multiple sites in Canada and Africa. The study will last for 365 days for each participant, not including the

Who is the study for?

This trial is for HIV-infected adults and adolescents aged 13-65 with controlled HIV (undetectable viral load, CD4 count ≥200 cells/mm3). Participants must be on antiretroviral therapy, not pregnant or breastfeeding, in good health as determined by a doctor, willing to attend all study visits, and agree to use effective contraception.Check my eligibility

What is being tested?

The ACHIV-Ebola trial tests the V920 Ebola vaccine against a saline placebo in HIV-positive individuals. It's randomized (participants are randomly assigned to groups), placebo-controlled (some get no active treatment), multi-site (conducted at different locations), and double-blind (neither participants nor researchers know who gets what treatment).See study design

What are the potential side effects?

While specific side effects aren't listed here, vaccines like V920 may cause reactions at the injection site, flu-like symptoms such as fever or fatigue, muscle pain, headache or allergic reactions. Side effects can vary from mild to severe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on HIV medication and my viral load is undetectable.

Select...

I am an HIV-positive person aged 13 to 65 and not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the number of vaccine related sae's from signing the consent form to day 365 will be recorded and summarized.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the number of vaccine related sae's from signing the consent form to day 365 will be recorded and summarized.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the number of vaccine related sae's from signing the consent form to day 365 will be recorded and summarized. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HIV Infections

Secondary outcome measures

Antibodies, Phospho-Specific

Trial Design

5Treatment groups

Active Control

Group I: Group 5: HIV infected adults and adolescents CD4 ≥ 200 cells/mm^3 with 2 dosesActive Control2 Interventions

Participants will be randomly assigned to receive two dosse of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo

Group II: Group 1: 50 HIV-infected adults CD4 ≥ 500 cells/mm^3Active Control2 Interventions

Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo

Group III: Group 2: 50 HIV-infected adults CD4 > 350 and < 500 cells/mm^3Active Control2 Interventions

Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo

Group IV: Group 3: 50 HIV-infected adults CD4 ≥ 200 and ≤ 350 cells/mm^3Active Control2 Interventions

Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of theV920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo

Group V: Group 4: HIV infected adolescents CD4 ≥ 200 cells/mm^3Active Control2 Interventions

Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cecile TremblayLead Sponsor

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,060,896 Total Patients Enrolled

International Development Research Centre, CanadaOTHER_GOV

15 Previous Clinical Trials

18,162 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial currently open for enrollment?

"As per clinicaltrials.gov, the present trial is not in active recruitment. The data was initially shared on August 1st, 2017 and last revised by March 27th, 2023. Despite this particular study being closed for enrollment currently, there are alternative eight trials available for prospective participants."

Answered by AI

Is the clinical trial accepting individuals above the age of 30?

"To be considered for this study, individuals must fall within the age range of 13 to 65. There are separate studies available for those under 18 (comprising four trials) and patients over 65 years old (consisting of seven distinct studies)."

Answered by AI

Which specific criteria must individuals meet in order to be deemed suitable candidates for involvement in this clinical trial?

"This clinical trial seeks to enroll 250 individuals aged between 13 and 65 who are currently afflicted with the Ebola virus. Eligible participants must meet specific requirements: they should be males or non-pregnant, non-breastfeeding females, within the age range of 13 to 65 at screening; under antiretroviral therapy with an undetectable viral load (<40 c/ml); possess CD4 T cell counts ≥200 cells/mm3; provide written informed consent (or assent for adolescents) after thoroughly reviewing the consent form and having ample opportunity to discuss the study with a qualified investigator or delegate; exhibit no significant"

Answered by AI

What is the risk level associated with administering 2 doses of treatment to patients in Group 5, which consists of HIV-infected adults and adolescents with a CD4 count greater than or equal to 200 cells/mm^3?

"The safety assessment for Group 5, comprising HIV-infected adults and adolescents with CD4 counts of at least 200 cells/mm^3 receiving two doses, is rated as a 2 on the scale. This rating indicates that while there are some existing safety data, no evidence supports efficacy in this Phase 2 trial context."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola

Cecile Tremblay 2017. "African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03031912.

All > Ebola