N/A
Completed N=114
Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine Trial
Source: ClinicalTrials.gov NCT00337181 ↗Enrolled (actual)
114
Serious AEs
—
Results posted
Aug 2018
Primary outcomePrimary: Number of Participants Reaching Clinical Long Term Component Endpoints — 3; 5; 18; 23 Participants
Summary
This protocol will study the clinical course of HIV-infection among volunteers who have received either a placebo injection or the experimental vaccine combination of ALVAC-HIV and AIDSVAX B/E prior to HIV-1 infection in reference to study NCT00223080 RV144. The study will assess whether those who received the experimental vaccine combination have a slower progression of HIV disease compared to those who received the placebo injection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reaching Clinical Long Term Component Endpoints |
3; 5; 18; 23; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- All individuals who become HIV-infected after receiving experimental vaccine or placebo in the RV144 clinical trial if they received at least one injection.
- The volunteer must give written, informed consent.
Exclusion Criteria
- Persons who have a medical or psychiatric disorder, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
- Persons who become HIV-infected after the completion of the RV144 protocol.
Data sourced from ClinicalTrials.gov (NCT00337181). 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. Informational only — not medical advice.