NCT00474370

Vicriviroc in HIV-Treatment Experienced Subjects (Study P04889AM8)(COMPLETED)

Completed Phase 3 Last updated 30 August 2022

What this trial tests

Phase 3 trial testing Vicriviroc in HIV Infections in 400 participants. Completed in 26 October 2010.

Timeline

15 May 2007

Primary endpoint
24 August 2009

26 October 2010

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	400
Start date	15 May 2007
Primary completion	24 August 2009
Estimated completion	26 October 2010

Drugs / interventions tested

• Vicriviroc — full drug profile →
• Placebo

Conditions studied

• HIV Infections — all drugs for HIV Infections →
• Acquired Immunodeficiency Syndrome — all drugs for Acquired Immunodeficiency Syndrome →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

16 and older, any sex, with HIV Infections or Acquired Immunodeficiency Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells that fight infection). Previous smaller studies in HIV treatment-experienced patients, have shown that vicriviroc is safe and effective. The purpose of this study is to confirm the previous findings in a larger phase 3 study over a 48-week period, and show that when taken in combination with other appropriate HIV drugs, vicriviroc can decrease the level of HIV (viral load) in the blood and that it is well tolerated.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. CCL5/CCR5 axis in human diseases and related treatments.
   Zeng Z, Lan T, Wei Y, Wei X. · · 2022 · cited 254× · PMID 34514075 · DOI 10.1016/j.gendis.2021.08.004
2. New genetic and epigenetic insights into the chemokine system: the latest discoveries aiding progression toward precision medicine.
   Xu H, Lin S, Zhou Z, Li D, et al · · 2023 · cited 37× · PMID 37198402 · DOI 10.1038/s41423-023-01032-x
3. Vicriviroc plus optimized background therapy for treatment-experienced subjects with CCR5 HIV-1 infection: final results of two randomized phase III trials.
   Caseiro MM, Nelson M, Diaz RS, Gathe J, et al · · 2012 · cited 29× · PMID 22634184 · DOI 10.1016/j.jinf.2012.05.008
4. HIV-1 Entry and Prospects for Protecting against Infection.
   Bruxelle JF, Trattnig N, Mureithi MW, Landais E, et al · · 2021 · cited 10× · PMID 33499233 · DOI 10.3390/microorganisms9020228