This is a double-blind Phase 2a study to test the safety and efficacy of an investigational HIV drug, amdoxovir (300 mg or 500 mg twice daily) compared with tenofovir DF 300 mg once daily in HIV-1 infected antiretroviral therapy-experienced subjects who are currently failing antiretroviral therapy. There are three treatment groups (N=45). Subjects will be randomized to receive either amdoxovir 300 mg twice daily (n=15) or amdoxovir 500 mg twice daily (n=15) or tenofovir DF 300 mg once daily (n=15); each in combination with zidovudine 300 mg twice daily. The study will assess initially amdoxovir (300 mg or 500 mg twice daily) or tenofovir DF 300 mg once daily, both in combination zidovudine 300 mg twice daily plus failing third drug, but then with lopinavir/ritonavir (400 mg/100 mg twice daily) after Week 2. Subjects who received amdoxovir (300 mg or 500 mg twice daily) and benefited from the drug may choose to enroll in the 36-week open-label study.
Name: amdoxovir 300 mg bid
Description: 2 x 150 mg capsules bidType: Drugamdoxovir 300 mg bid
Name: amdoxovir 500 mg bid
Description: 2 x 250 mg capsules bidType: Drugamdoxovir 500 mg bid
Name: tenofovir DF 300 mg qd
Description: 1 x 300 mg tablet once dailyType: Drugtenofovir DF 300 mg qd
Allocation: Randomized
Parallel Assignment
There are 4 SNPs
- Genotypic resistance testing at screening indicating K65R, L74V, Q151M mutation. --- K65R ---
- Genotypic resistance testing at screening indicating K65R, L74V, Q151M mutation. --- K65R --- --- L74V ---
A Phase IIa, Randomized, Double-blind, Active-controlled, 12-week Study of Amdoxovir (Two Doses) Versus Tenofovir DF, in Combination With Zidovudine in HIV-1 Treatment-experienced Subjects With M184I/V Mutation in Addition to 0-2 Confirmed Thymidine Analog Mutations.. --- M184I ---
- Has M184I/V mutation in addition to 0-2 thymidine analog mutations (TAMs) at screening. --- M184I ---
- Genotypic resistance testing at screening indicating K65R, L74V, Q151M mutation. --- K65R --- --- L74V --- --- Q151M ---