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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: The Ojai Foundation

Current Primary Outcome: CD4+ percentage (change in HIV-1 seropositive patients) [ Time Frame: 9 MONTHS ]

HIV+ patients with CD4+ count over 350 had their CD4 count/percentage measured at beginning, at 15 days, at 1 month, 3 months, 6 months and 9 months (end).


Original Primary Outcome: Same as current

Current Secondary Outcome: Clinical assessment of evidence of AIDS or other serious illness [ Time Frame: 9 MONTHS ]

HIV+ patients with CD4 counts over 200 on ARV drugs were given clinical assessment and testing for evidence of opportunistic infections (AIDS) at each visit for blood testing: (Beginning, 15 days, 1 month, 3 months, 6 months, & 9 months (end).


Original Secondary Outcome: Same as current

Information By: The Ojai Foundation

Dates:
Date Received: August 2, 2010
Date Started: March 2008
Date Completion:
Last Updated: August 2, 2010
Last Verified: August 2010