drugset / Trial / NCT01174914

Effectiveness Study Low-Dose Naltrexone Versus ARV's for HIV+

NCT01174914

Phase 2 Completed 171 enrolled The Ojai Foundation
RandomizedParallel-groupSingle-blindPrevention

Summary

In the vast majority of those infected with HIV virus who are untreated, there is deterioration in immune health over a period of months or years inevitably leading to full-blown AIDS and demise. Treatment with ARV's stop or slow down this deterioration if started before a certain degree of progression occurs and has saved millions of lives. The investigators' study hypothesis is that effectiveness of a very low dose of an FDA-approved medication, naltrexone hydrochloride, (Low-Dose Naltrexone, or LDN) will compare favorably to ARV's to prevent progression of HIV+ toward immune deterioration and full-blown AIDS.

Timeline

Start
2008-03
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Naltrexone Small molecule 3 mg Oral
Comparator Azidothimidine Unknown
Comparator Efavirenz Other / unclassified
Comparator Lamivudine Other / unclassified
Comparator Lopinavir Other / unclassified
Comparator Nevirapine Small molecule
Comparator Stavudine Other / unclassified
Comparator Tenofovir Small molecule
Comparator emtricitabine Other / unclassified

Indications

No indication recorded.