Discontinuation of primary and secondary prophylaxis for opportunistic infections in HIV-infected patients who had CD4+ cell count <200 cells/mm(3) but undetectable plasma HIV-1 RNA: an open-label randomized controlled trial

AIDS Patient Care STDS. 2013 Feb;27(2):71-6. doi: 10.1089/apc.2012.0303.

Abstract

Abstract The CDC recommends discontinuing opportunistic infections (OIs) prophylaxis in HIV-infected patients who have CD4+ cell count >200 cells/mm(3) after receiving combination antiretroviral therapy (cART). A prospective randomized controlled trial was conducted at Chiang Mai University Hospital from June 1, 2009 to January 31, 2012 in 74 adult HIV-infected patients who had received cART and had CD4+ cell count <200 cells/mm(3) but plasma HIV-1 RNA<50 copies/ml. Forty-three patients (58.1%) were male and the mean age was 41.8±8.1 years; 68 (91.9%) and 59 (79.7%) patients were receiving co-trimoxazole and antifungal prophylaxis, respectively. The median CD4+ cell counts at enrollment were 142 (IQR 108, 161) and 158 (IQR 141, 176) cells/mm(3) among patients who discontinued and continued OIs prophylaxis, respectively (p value=0.041). One of 37 patients (2.7%) in the discontinuation group developed Pneumocystis jiroveci pneumonia, giving the incidence rate of 1.57/1000 person-months. None of the 37 patients in the continuation group developed OIs. The difference in the prevention rates of OIs between groups was -2.7% (95% CI -7.9, 2.5). In conclusion, in the setting where plasma HIV-RNA measurement is available, e.g., Asia-Pacific region, discontinuation of prophylaxis is considerably safe in HIV-infected patients receiving cART with undetectable plasma HIV-RNA but incomplete immune recovery.

Trial registration: ClinicalTrials.gov NCT01392430.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • AIDS-Related Opportunistic Infections / epidemiology
  • AIDS-Related Opportunistic Infections / immunology*
  • AIDS-Related Opportunistic Infections / prevention & control
  • Adult
  • Anti-HIV Agents / administration & dosage*
  • CD4 Lymphocyte Count
  • Disease Progression
  • Female
  • Follow-Up Studies
  • HIV Seropositivity / drug therapy
  • HIV Seropositivity / epidemiology
  • HIV Seropositivity / immunology*
  • HIV-1 / genetics
  • HIV-1 / isolation & purification*
  • Humans
  • Lymphocyte Activation
  • Male
  • Post-Exposure Prophylaxis*
  • Primary Prevention
  • Prospective Studies
  • RNA, Viral / isolation & purification
  • Secondary Prevention
  • Thailand / epidemiology
  • Viral Load
  • Withholding Treatment*

Substances

  • Anti-HIV Agents
  • RNA, Viral

Associated data

  • ClinicalTrials.gov/NCT01392430