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NCT00337181
Extended Evaluation of the Virologic, Immunologic, and Clinical Course of Volunteers Who Become HIV-1 Infected During Participation in a Phase III Vaccine Trial of ALVAC-HIV and AIDSVAX® B/E.
trial in HIV-1 in 114 participants. Completed in 1 June 2011.
1 March 2011
Quick facts
| Lead sponsor | U.S. Army Medical Research and Development Command |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 114 |
| Start date | 1 May 2006 |
| Primary completion | 1 March 2011 |
| Estimated completion | 1 June 2011 |
| Sites | 1 location across Thailand |
Conditions studied
- HIV-1 — all drugs for HIV-1 →
Sponsor
U.S. Army Medical Research and Development Command
Who can join
Adults 18 to 31, any sex, with HIV-1. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Participants Reaching Clinical Long Term Component Endpoints
Time frame: 66 months
Evaluate the vaccine effect on clinical long term endpoints: CD4 is for CD4\<350 endpoint; ART is for initiation of highly-active antiretroviral therapy (HAART) endpoint; ADI is for AIDS-defining illness endpoint; A combination of multiple endpoints is listed in order of occurrences of the endpoints
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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RV144 HIV-1 vaccination impacts post-infection antibody responses.
Mdluli T, Jian N, Slike B, Paquin-Proulx D, et al · · 2020 · cited 28× · PMID 33290394 · DOI 10.1371/journal.ppat.1009101 -
Post-Immune Antibodies in HIV-1 Infection in the Context of Vaccine Development: A Variety of Biological Functions and Catalytic Activities.
Timofeeva A, Sedykh S, Nevinsky G. · · 2022 · cited 12× · PMID 35335016 · DOI 10.3390/vaccines10030384 -
HIV-1 infections with multiple founders associate with the development of neutralization breadth.
Lewitus E, Townsley SM, Li Y, Donofrio GC, et al · · 2022 · cited 8× · PMID 35303045 · DOI 10.1371/journal.ppat.1010369 -
Immunotherapy with Cell-Based Biological Drugs to Cure HIV-1 Infection.
Siracusano G, Lopalco L. · · 2021 · cited 1× · PMID 35011639 · DOI 10.3390/cells11010077 -
Recent Advances in Nanoparticle-Based Antiretroviral Drug Delivery Systems for HIV Treatment and Prevention: A Comprehensive Review.
Das G, Shin HS, Patra JK. · · 2025 · PMID 41287764 · DOI 10.2147/ijn.s540578
Verify or expand the search:
- PubMed search for NCT00337181
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for HIV-1
Currently open trials in the same condition.
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- NCT05612178 — A Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Persistent Viral Reservoirs · Phase 1 · active not recruiting
- NCT00980538 — TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants · Phase 3 · active not recruiting
Other U.S. Army Medical Research and Development Command trials
Trials by the same sponsor.
- NCT05423418 — Safety, Tolerability, and Immunogenicity of ALFQ in a HIV Vaccine Containing A244 and B.65321 in Healthy Adults · Phase 1 · completed
- NCT05348993 — Single or Repeat Dose of G03-52-01 in Adult Subjects · Phase 2 · completed
- NCT04658667 — HIV Vaccine in HIV-uninfected Adults · Phase 1 · completed
- NCT04333459 — Safety and Immunogenicity of a Hantaan Virus DNA Vaccine and a Puumala Virus DNA Vaccine, For The Prevention of Hemorrha · Phase 2 · unknown
- NCT03867162 — FY15-14: Tularemia Vaccine Protocol (NDBR Lot 4) · Phase 2 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00337181 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by U.S. Army Medical Research and Development Command
- Last refreshed: 21 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00337181.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing