Episodic antiretroviral therapy increases HIV transmission risk compared with continuous therapy: results of a randomized controlled trial

J Acquir Immune Defic Syndr. 2008 Oct 1;49(2):142-50. doi: 10.1097/QAI.0b013e318183a9ad.


Objective: To compare the HIV transmission risk among patients randomized to episodic versus continuous antiretroviral therapy.

Design: This was a substudy of the Strategies of Management of Antiretroviral Therapy study, in which patients were randomized to continuous versus CD4-guided episodic antiretroviral therapy. Participants were surveyed about sexual activity and needle sharing and had laboratory testing for gonorrhea, chlamydia, and syphilis.

Results: A total of 883 patients were enrolled in this study, the mean age of the patients was 45 years, 25% were women, and 78% were on antiretroviral therapy. At baseline, 136 participants (15.4%) had high-risk behavior (vaginal or anal sex without a condom, needle sharing, or incident bacterial sexually transmitted infection). After randomization, the proportion of participants reporting high-risk behavior was stable and did not differ by randomized arm (P = 0.39). Among participants off therapy at baseline, high-risk behavior was less common 4 months after randomization among those who were randomized to start antiretroviral therapy (P = 0.03). HIV transmission risk (high-risk behavior while HIV RNA level >1500 copies/mL) with partners perceived to be HIV uninfected was higher in the episodic therapy arm (P = 0.02).

Conclusions: Patients on episodic antiretroviral therapy did not decrease high-risk behavior, and because HIV RNA levels were higher, this strategy may result in increased HIV transmission.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Antiviral Agents / administration & dosage*
  • Antiviral Agents / therapeutic use
  • CD4 Lymphocyte Count
  • Female
  • HIV Infections / drug therapy
  • HIV Infections / psychology*
  • HIV Infections / transmission*
  • Humans
  • Male
  • Middle Aged
  • RNA, Viral / blood
  • Risk Assessment*
  • Risk-Taking
  • Viral Load


  • Antiviral Agents
  • RNA, Viral