AIDS Clinical Trial Research Group (ACTG), Studies: A5306, A5254, A5298
Investigator: Diane Havlir, MD
Sponsor: Brigham and Women's Hospital
A5306 is a phase 1 study of the novel anti - TB agent PA824, a nitroimidazopyran, incombination with lopinavir/r, EFV, and rifampin, evaluating drug-drug interactions and safety in healthy volunteers. With PA824 entering phase 2 trials in combination with moxifloxacin and pyrazinamide, PK data will be invaluable for planning future phase 2 and 3 trials.
A5254 (co-chairs: Caroline Shiboski/Judy Aberg): Assessment of HIV -Related Oral Mucosal Disease and Use of Saliva in Measuring HIV Viral Load
This non- randomized protocol is a cross - sectional study proposed jointly by the three OHARA PIs and being conducted in five US sites and onenon -US site. The project will accomplish three goals:
1) to assess the validity of oral diagnoses made by trained examiners as compared to oral medicine -trained clinicians, while establishing the background prevalence of HIV -related oral mucosal lesions in these sites; 2) to describe the relationship between HIV-1 viral load in plasma and saliva; and 3) to assess the background level of Candida colony -forming-units in the oral cavity in relation to clinical signs of oral candidiasis. Target enrollment is 360 HIV-1 infected adult males and females 18 years or older, with or without prior antiretroviral (ARV) treatment.
A5298 Oral component A Randomized, Double-Blinded, Placebo-Controlled, Phase III Trial of the Quadrivalent HPV Vaccine to Prevent Anal Human Papillomavirus Infection in HIV -Infected Men
A5298 is a phase III, double blinded, placebo controlled study with stratification by CD4+ cell count and HIV-1 RNA viral load to assess the immunogenicity, safety, and tolerability of the quadrivalent human papillomavirus (HPV) recombinant vaccine (GARDASIL) directed against types 6, 11, 16, and 18. It will enroll 464 men. Objectives of the oral component are:
1) to identify and quantify HPV types in the oral cavity at baseline and after the vaccination series; and 2) to compare oral and anogenital compartmental shedding and strain variation of HPV at baseline and after the vaccination series.