A Randomised Trial of Subcutaneous Intermittent Interleukin-2 without Antiretroviral Therapy in HIV-Infected Patients: The UK–Vanguard Study
2006

IL-2 Therapy without Antiretroviral Drugs in HIV

Sample size: 36 publication Evidence: moderate

Author Information

Author(s): Youle Mike, Emery Sean, Fisher Martin, Nelson Mark, Fosdick Lisa, Janossy George, Loveday Clive, Sullivan Ann, Herzmann Christian, Wand Handan, Davey Richard T Jr., Johnson Margaret A, Tavel Jorge A, Lane H. Clifford

Primary Institution: Royal Free Centre for HIV Medicine, London, United Kingdom

Hypothesis

Intermittent cycles of IL-2 would result in significant increases in CD4 T lymphocyte counts relative to no therapy.

Conclusion

Intermittent subcutaneous IL-2 without concomitant antiretroviral therapy was well tolerated and produced significant increases in CD4 T lymphocyte counts without adversely affecting plasma HIV RNA levels.

Supporting Evidence

  • Participants receiving IL-2 had a mean increase in CD4 T lymphocyte count of 129 cells/mm3 compared to 13 cells/mm3 in the control group.
  • Significant increases in CD4 cell count were observed for both IL-2 dose groups compared to the control group.
  • There were no significant differences in plasma HIV RNA levels between the IL-2 and control groups.

Takeaway

This study tested a treatment for HIV that uses a substance called IL-2 instead of regular HIV medicines. It found that IL-2 can help increase a type of immune cell without making the virus worse.

Methodology

This was a multicentre randomised three-arm trial conducted between September 1998 and March 2001 at three clinical centres in the United Kingdom.

Limitations

The results are limited by the short follow-up of patients and the lack of clinical endpoints such as disease progression.

Participant Demographics

Participants were 36 antiretroviral treatment naïve HIV-1-infected patients with baseline CD4 T lymphocyte counts of at least 350 cells/mm3.

Statistical Information

P-Value

p = 0.0009

Confidence Interval

95% CI for difference, 51.3–181.2 cells/mm3

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1371/journal.pctr.0010003

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