Field Performance of PIMA Point-of-Care Machine for CD4 Enumeration Under a Mobile HIV Counseling and Testing Program in Remote Fishing Communities of Lake Victoria, Uganda.

Uganda is among the most HIV/AIDS-afflicted countries, and many HIV-infected persons live in remote areas with poor access to health care. The success of HIV care programs relies in part on patient monitoring using CD4 T cell counts. We conducted an evaluation of the point-of-care PIMA test using BD FACSCount as a gold standard. One hundred fifty-one participants were enrolled, provided venous blood and samples tested at the point of care with the Alere PIMA™ CD4 Analyzer and the BD FACSCount in the UVRI-IAVI main laboratory. Correlation between the methods was assessed, as was the ability of the Pima Analyzer to predict values <200, <350, and ≥500 CD4 cells/mm3 when compared with BD FACSCount as the gold standard. A near-perfect positive Pearson correlation coefficient (r = 0.948; p < .0001) between the two methods was observed. The Alere PIMA Analyzer had a mean bias of -32.5 cells/mm3. The sensitivity and specificity, for PIMA to predict CD4 lymphocyte count less than 200 cells/mm3, were 71.4% and 100%, respectively; less than 350 cells/mm3 were 84.6% and 94.6%, respectively; and at CD4 count less than 500 cells/mm3 were 94.4% and 100%. The Alere Pima Analyzer provides reliable CD4 cell count measurement and is suitable for monitoring and screening eligible HIV patients in hard-to-reach settings.

High Transmitter CD4+ T-Cell Count Shortly after the Time of Transmission in a Study of African Serodiscordant Couples.

BACKGROUND: 2013 WHO guidelines recommend starting ART at CD4+ T-cell counts ≤500 cells/µL. We present the T-cell counts from adult Africans with HIV shortly following transmission to their sexual partners. METHODS: HIV-discordant couples in Zambia, Uganda and Rwanda were followed prospectively and received couples counseling and condoms. HIV uninfected partners were tested for HIV at least quarterly and HIV-infected partners received HIV care and referral for ART per national guidelines. Upon diagnosis of incident HIV infection in the previously HIV-uninfected partner, a blood sample was collected from both partners to measure CD4+ T-cells and perform viral linkage. The estimated date of infection (EDI) of the incident case was calculated based on testing history. EDI was unknown for suspected transmitting partners. RESULTS: From 2006-2011, 4,705 HIV-discordant couples were enrolled in this cohort, and 443 cases of incident HIV infection were documented. Virus linkage analysis was performed in 374 transmission pairs, and 273 (73%) transmissions were linked genetically. CD4 counts in the transmitting partner were measured a median of 56 days after EDI (mean:90.5, min:10, max:396). The median CD4 count was 339 cells/µl (mean:386.4, min:15, max:1,434), and the proportion of partners with a CD4+ T-cell count above 500/µl was 25% (95% CI:21, 31). CONCLUSIONS: In our cohort of discordant couples, 73% of HIV transmissions occurred within the relationship, and the transmitter CD4+ T cell count shortly after the transmission event was frequently higher than the WHO 2013 ART-initiation guidelines.

A phase I double blind, placebo-controlled, randomized study of a multigenic HIV-1 adenovirus subtype 35 vector vaccine in healthy uninfected adults.

BACKGROUND: We conducted a phase I, randomized, double-blind, placebo-controlled trial to assess the safety and immunogenicity of escalating doses of two recombinant replication defective adenovirus serotype 35 (Ad35) vectors containing gag, reverse transcriptase, integrase and nef (Ad35-GRIN) and env (Ad35-ENV), both derived from HIV-1 subtype A isolates. The trial enrolled 56 healthy HIV-uninfected adults. METHODS: Ad35-GRIN/ENV (Ad35-GRIN and Ad35-ENV mixed in the same vial in equal proportions) or Ad35-GRIN was administered intramuscularly at 0 and 6 months. Participants were randomized to receive either vaccine or placebo (10/4 per group, respectively) within one of four dosage groups: Ad35-GRIN/ENV 2×10(9) (A), 2×10(10) (B), 2×10(11) (C), or Ad35-GRIN 1×10(10) (D) viral particles. RESULTS: No vaccine-related serious adverse event was reported. Reactogenicity events reported were dose-dependent, mostly mild or moderate, some severe in Group C volunteers, all transient and resolving spontaneously. IFN-γ ELISPOT responses to any vaccine antigen were detected in 50, 56, 70 and 90% after the first vaccination, and in 75, 100, 88 and 86% of Groups A-D vaccine recipients after the second vaccination, respectively. The median spot forming cells (SFC) per 10(6) PBMC to any antigen was 78-139 across Groups A-C and 158-174 in Group D, after each of the vaccinations with a maximum of 2991 SFC. Four to five HIV proteins were commonly recognized across all the groups and over multiple timepoints. CD4+ and CD8+ T-cell responses were polyfunctional. Env antibodies were detected in all Group A-C vaccinees and Gag antibodies in most vaccinees after the second immunization. Ad35 neutralizing titers remained low after the second vaccination. CONCLUSION/SIGNIFICANCE: Ad35-GRIN/ENV reactogenicity was dose-related. HIV-specific cellular and humoral responses were seen in the majority of volunteers immunized with Ad35-GRIN/ENV or Ad35-GRIN and increased after the second vaccination. T-cell responses were broad and polyfunctional. TRIAL REGISTRATION: ClinicalTrials.gov NCT00851383.