Evaluating the Safety and Immune Response of DNA/MVA Vaccines in HIV-1-Infected Young Adults Taki… (NCT01909414) | Clinical Trial Compass
WithdrawnPhase 1
Evaluating the Safety and Immune Response of DNA/MVA Vaccines in HIV-1-Infected Young Adults Taking Anti-HIV Medications
0
Plain-language summary
The purpose of this study is to evaluate the safety of two HIV vaccines in HIV-1-infected young adults who are taking anti-HIV medications and have very low virus levels. This study will also look at how the immune system responds to the vaccines.
Who can participate
Age range
18 Years – 24 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* HIV-1 infected. More details on this criterion can be found in the protocol.
* Likely HIV-1 acquisition in North America or Europe (in the opinion of the site investigator)
* Likely HIV-1 acquisition from sexual transmission (in the opinion of the site investigator)
* On stable HAART, defined as at least three different antiretrovirals (ARVs) from two different classes, with plasma HIV-1 RNA levels fewer than 100 copies/mL for at least 12 months prior to screening. Furthermore, at least two plasma HIV-1 RNA levels fewer than 100 copies/mL (and none with plasma HIV-1 RNA levels 100 or more copies/mL), separated by at least 3 months must have been documented during the 6-month period prior to enrollment.
* Ability and willingness of participant to provide signed written informed consent
* CD4 count 400 cells/mm\^3 or greater at screening
* The following lab values (at screening visit):
* Creatine phosphokinase no higher than 5 times the upper limit of normal (ULN). More details on this criterion can be found in the protocol.
* Troponin I no more than 1.0 times ULN
* Hemoglobin greater than 10 g/dL
* Absolute neutrophil count greater than 1,000 mm\^3
* Platelets greater than 100,000 mm\^3
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no greater than 1.5 times ULN
* Total bilirubin no greater than 1.5 times ULN (less than 5 times ULN if taking atazanavir)
* Creatinine less than 2.0 mg/dL
* Female participants who eng…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Grade 3 or higher adverse events (AEs)
Timeframe: Measured through Week 120
2
Progression of HIV disease status: immunological decline
Timeframe: Measured through Week 120
3
Progression of HIV disease status: RNA 1,000 copies/mL or greater measured on two occasions at least 1 week apart
Timeframe: Measured through Week 120
4
Progression of HIV disease status: development of an AIDS-defining opportunistic infection or malignancy
Timeframe: Measured through Week 120
5
A greater than or equal to two-fold increase in the frequency of responding HIV-1 Gag-specific CD8 T cells between entry visit and Week 17 visit
Timeframe: Measured through Week 17
Trial details
NCT IDNCT01909414
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)