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Pilot study of once-daily simplification therapy with abacavir/lamivudine/zidovudine and efavirenz for treatment of HIV-1 infection
- Source :
- HIV clinical trials. 7(5)
- Publication Year :
- 2006
-
Abstract
- The purpose of this pilot study was to explore the efficacy and safety of the abacavir/lamivudine/zidovudine fixed-dose combination tablet administered as two tablets once daily (qd) versus one tablet twice daily (bid) in combination with efavirenz (EFV).This was a prospective, randomized, open-label, multicenter study with a 24-week treatment period in 7 outpatient HIV clinics in the United States. Patients currently receiving an initial regimen of abacavir/lamivudine/zidovudine bid plus EFV qd for at least 6 months with HIV-1 RNA50 copies/mL for at least 3 months and a screening CD4+ cell countor = 200 cells/mm3 were eligible. Thirty-six patients enrolled, and 35 (97%) completed the study. Participants were randomized to switch to 2 tablets of abacavir/lamivudine/zidovudine qd plus EFV qd (QD arm) or continue current treatment (BID arm) for 24 weeks.Efficacy, safety, and adherence were evaluated. Median baseline CD4+ cell count was 521 cells/mm3. At week 24, HIV-1 RNA50 copies/mL was achieved for 94% of participants in the QD arm and 89% in the BID arm by intent-to-treat, missing = failure analysis (95% confidence interval for difference:or = 0.29 to +0.18, p = 1.000). At week 24, median CD4+ cell count change from baseline was +26 cells/mm3 for the QD arm and -39 cells/mm3 for BID arm. One patient randomized to the QD arm met virologic failure criteria (confirmed HIV-1 RNA120 copies/mL) at week 20 and viral genotype showed M184V. After failure, this patient revealed he never took EFV throughout the entire study after randomization, effectively receiving only abacavir/lamivudine/zidovudine qd alone. Median adherence was slightly higher in the QD arm, although both arms had broad variability and overlapping interquartile ranges. Adverse events were infrequent and occurred with similar frequency between arms; treatment-related adverse events were abdominal pain, flatulence, nausea, headache, and abnormal dreams (1 patient [3%] for each adverse event). No patients withdrew due to adverse events, and no abacavir hypersensitivity reactions were reported.In this pilot study of patients suppressed on abacavir/lamivudine/zidovudine bid plus EFV, 94% of participants switching to abacavir/lamivudine/zidovudine qd plus EFV maintained virologic suppression, compared to 89% of participants continuing abacavir/lamivudine/zidovudine bid plus EFV.
- Subjects :
- Adult
Cyclopropanes
Male
medicine.medical_specialty
Efavirenz
Anti-HIV Agents
Administration, Oral
HIV Infections
Pilot Projects
Drug Administration Schedule
law.invention
Treatment Refusal
Zidovudine
chemistry.chemical_compound
Randomized controlled trial
Abacavir
law
Internal medicine
Oxazines
medicine
Humans
Pharmacology (medical)
Treatment Failure
Abacavir/Lamivudine/Zidovudine
business.industry
virus diseases
Lamivudine
Nausea
Middle Aged
Dideoxynucleosides
United States
Surgery
Abdominal Pain
Benzoxazines
Clinical trial
Regimen
Infectious Diseases
Treatment Outcome
chemistry
Alkynes
HIV-1
RNA, Viral
Drug Therapy, Combination
Female
business
medicine.drug
Tablets
Subjects
Details
- ISSN :
- 15284336
- Volume :
- 7
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- HIV clinical trials
- Accession number :
- edsair.doi.dedup.....86efdbdca410e28f42355c414695964e