Abstract | OBJECTIVE: To assess the antiviral efficacy, safety, and adherence in subjects who switched to Trizivir following long-term HIV-1 RNA suppression. STUDY DESIGN: METHODS: Subjects were randomized 1:1 to continue their current treatment or to switch to a simplified treatment with Trizivir administered twice daily. Assessments included plasma HIV-1 RNA, lymphocyte counts, clinical laboratory evaluations, adverse events, and adherence to treatment (obtained via subject self-report). Treatment failure was defined as a plasma viral load of >/= 400 HIV-1 RNA copies/mL on two consecutive occasions or premature discontinuation of randomized treatment. RESULTS: At week 48, the proportion of treatment failures in Trizivir arm (23/106, 22%) was noninferior to that observed in continued arm (23/103, 22%) with a treatment difference stratified by prior ART of 1.2%[-10.1; 12.5]. Incidence of adverse events was similar in both treatment groups. The incidence of possible hypersensitivity reaction in the Trizivir trade mark arm was 10%. Significant reductions in cholesterol and triglyceride plasma levels were observed in the Trizivir arm (P < 0.001 and P = 0.006, respectively). CONCLUSION: Switching to Trizivir offers a potent and simplified regimen with equivalent efficacy and significant improvement in lipid abnormalities compared to continued triple therapy.
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Authors | C Katlama, S Fenske, B Gazzard, A Lazzarin, N Clumeck, J Mallolas, A Lafeuillade, J-P Mamet, L Beauvais, AZL30002 European study team |
Journal | HIV medicine
(HIV Med)
Vol. 4
Issue 2
Pg. 79-86
(Apr 2003)
ISSN: 1464-2662 [Print] England |
PMID | 12702127
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antiviral Agents
- Dideoxynucleosides
- Drug Combinations
- Protease Inhibitors
- RNA, Viral
- Triglycerides
- abacavir, lamivudine, and zidovudine drug combination
- Lamivudine
- Zidovudine
- Cholesterol
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Topics |
- Adult
- Aged
- Antiretroviral Therapy, Highly Active
- Antiviral Agents
(therapeutic use)
- Chi-Square Distribution
- Cholesterol
(blood)
- Dideoxynucleosides
(therapeutic use)
- Drug Combinations
- Drug Hypersensitivity
- Female
- HIV Infections
(blood, drug therapy, virology)
- HIV-1
(genetics)
- Humans
- Lamivudine
(therapeutic use)
- Male
- Middle Aged
- Protease Inhibitors
(administration & dosage)
- RNA, Viral
(blood)
- Statistics, Nonparametric
- Triglycerides
(blood)
- Viral Load
- Zidovudine
(therapeutic use)
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