Experimental NRTI MIV-310 Efficiently Reduces HIV Viral Load in Patients Failing Multiple Drug Therapy: Results from a 4-week Phase II Study

Drug resistance is an increasing problem in the treatment of HIV infection. MIV-310 (alovudine), an experimental nucleoside reverse transcriptase inhibitor (NRTI), potently inhibits the replication of highly mutated strains of HIV in vitro.

French researchers examined the efficacy of MIV-310 in highly pre-treated patients.

In a phase II pilot study, 15 patients failing a current antiretroviral therapy with at least two thymidine-associated mutations (TAM) were given MIV-310 7.5 mg once daily for 4 weeks, in addition to their ongoing treatment.

The primary endpoint was the plasma viral load reduction at week 4.

Results

At baseline, the median viral load was 3.93 log10 copies/ml and the median CD4 cell count was 360 cells/mm3.

After 4 weeks of MIV-310 administration, the median decrease in viral load was -1.13 log10. Interestingly, the median reduction was only -0.57 log10 in the four patients on stavudine (Zerit), contrasting with a median reduction of -1.88 log10 in the 11 patients not receiving concomitant stavudine.

The viral load fell by a median of -1.60 log10 in patients with two to three TAM

(n = 7), and by -1.88 log10 in patients with four or five TAM (n = 8). The viral load rebounded in all patients after MIV-310 cessation.

No mutations were found in the reverse transcriptase coding region during MIV-310 treatment.

MIV-310 was well tolerated, with no serious adverse events and no treatment withdrawals.

Conclusion

MIV-310 7.5 mg/day efficiently reduced the HIV viral load in patients failing a multiple-drug regimen. Further studies with different dosages and longer administration times are urgently needed.

Departement des Maladies Infectieuses et Tropicales/INSERM E0214, Hopital Pitie-Salpetriere, Paris, France.

Summary articles on all drugs in NRTI drug class

Articles on experimental anti-HIV drugs

09/20/04

Reference
C Katlama and others. MIV-310 reduces HIV viral load in patients failing multiple antiretroviral therapy: results from a 4-week phase II study. AIDS 18(9): 1299-1304. June 18, 2004.