Adding New Drugs for HIV Infected Patients Failing Current Therapy

Summary

Even though powerful anti-HIV drug combinations have been successful in patients with little or no prior anti-HIV therapy, studies have shown that these treatments are less effective in patients who have been treated with nucleoside analogues. This study will test the safety and effectiveness of adding one or two new drugs to a personalized anti-HIV regimen for patients whose previous HIV treatments have failed.

Timeline

Start

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Primary completion

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Completion

2004-11

Outcome

Missed primary endpoint

paper the median AAUCMB was -0.9 log10 copies/mL (95% CI = -2.2, -.0.1) in the DAPD arm and -0.9 log10 copies/ml (95% CI = -1.1, -0.1) in the placebo arm (P = 0.69). PMID 16964830 ↗

paper Time to first serious AE did not differ between arms (P = 0.91). PMID 16964830 ↗

paper did not add statistically significant antiretroviral activity at 24 weeks in this small study. PMID 16964830 ↗

Publications

• Results Gripshover BM, Ribaudo H, Santana J, Gerber JG, Campbell TB, Hogg E, Jarocki B, Hammer SM, Kuritzkes DR; A5118 Team. Amdoxovir versus placebo with enfuvirtide plus optimized background therapy for HIV-1-infected subjects failing current therapy (AACTG A5118). Antivir Ther. 2006;11(5):619-23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	amdoxovir	Small molecule	300 mg	Oral
Background	Enfuvirtide	Peptide	—	Other

Indications