CTN 167: Options with antiretrovirals (OPTIMA)
A tri-national (Canada, UK, USA) randomized, controlled trial to determine the optimal management of patients with HIV infection for whom first and second-line highly active antiretroviral therapy has failed
About the Study
This study set out to find the best therapy for HIV-infected persons in whom at least two conventional HAART regimens had failed. Rather than testing the efficacy of individual drugs, Researchers compared four treatment strategies consisting of drug-free periods and drug combinations. Therapies were also measured to find the one most cost-effective for ART-experienced HIV-infected individuals.
Study Approach
This was a six-year study with 368 participants across forty-eight sites in Canada, the U.S. and the United Kingdom. Eligible participants were randomly assigned to an antiretroviral drug-free period (ARDFP) of at least three months or no ARDFP, and were also randomly designated to receive either a standard ART or a mega-ART.
The four treatment groups:
- Drug free period + standard ART— four or fewer anti-HIV drugs
- Standard ART without a drug free period
- Drug free period + mega-ART
- Mega-ART— five or more anti-HIV drugs without a drug free period
Drug combinations were highly individualized and determined by the patient and their physician in accordance with treatment history and genotype profile. All participants underwent viral resistance testing prior to being randomly assigned to the difference treatment groups.
Study Population
The study was open to male and female patients with advanced HIV disease in whom ARV regimens (taken for at least three months) including all of the three main available classes of ARV drugs had failed. Participants must have had a maximum CD4 cell count of 300 cells/mm3. A total of 368 individuals were enrolled (98% male, mean age 48).
Results
No significant clinical differences in AIDS, survival or severe adverse events were seen between the four management arms. As expected, the treatment interruption arm saw a rise in viral load and a decline in CD4 cell count. Once ARVs were resumed, viral load decreased and CD4 cell count increased, and by week 24, no differences were seen between the treatment interruption and continuation study arms. Median CD4 counts increased and plasma viral load declined from baseline over the course of the study in all groups.
Conclusions
OPTIMA has shown that there are no safety concerns with an ARDFP. Ongoing examinations will be continued to assess the treatment groups further.
Background
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Study Approach
This was a six-year study with 368 participants across forty-eight sites in Canada, the U.S. and the United Kingdom. Eligible participants were randomly assigned to an antiretroviral drug-free period (ARDFP) of at least three months or no ARDFP, and were also randomly designated to receive either a standard ART or a mega-ART.
The four treatment groups:
Drug free period + standard ART” four or fewer anti-HIV drugs
Standard ART without a drug free period
Drug free period + mega-ART
Mega-ART” five or more anti-HIV drugs without a drug free period
Drug combinations were highly individualized and determined by the patient and their physician in accordance with treatment history and genotype profile. All participants underwent viral resistance testing prior to being randomly assigned to the difference treatment groups.
Study Population
The study was open to male and female patients with advanced HIV disease in whom ARV regimens (taken for at least three months) including all of the three main available classes of ARV drugs had failed. Participants must have had a maximum CD4 cell count of 300 cells/mm3. A total of 368 individuals were enrolled (98% male, mean age 48).
Investigators
Here’s who is leading this study.
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