NCT01174914

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

Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: The Ojai Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The LDN (low-dose naltrexone) vs ARV (anti-retroviral drugs) Effectiveness Study in Mali sponsored by The Ojai Foundation in California-USA is a clinical research study endorsed and approved by the Malian Government. Naltrexone hydrochloride is a generic, FDA-approved since 1998 drug, an opioid antagonist that has clinically shown immune enhancing/modulating qualities in very low dosage and may offer an alternative to ARV drugs that is effective, non-toxic, easily available, inexpensive, with simple once-daily at bedtime administration. LDN capsules must be created by compounding pharmacists to get these ultra-small doses. Due to toxicity of current ARV drugs and need for special medical management young HIV infected children are largely neglected particularly in developing countries; LDN can also be made available in a transdermal cream for infants and children who are HIV infected.

Conditions

• HIV Seropositivity

Interventions

Type	Name	Description
OTHER	ARV's + Placebo	Patients continued ARV's plus a placebo nightly for 9 months
DRUG	Naltrexone	Naltrexone, Low-Dose (3mg) given once daily at bedtime for 9 months
DRUG	Naltrexone + ARV's	Patients were given standard ARV's plus Naltrexone (Low Dose) 3mg nightly.

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2010-08-04
• Last updated: 2010-08-04

Locations

1 site across 1 country: Mali