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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01174914
Enrollment
171
Registered
2010-08-04
Start date
2008-03-31
Completion date
2010-03-31
Last updated
2010-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Seropositivity

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 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.

Interventions

OTHERARV's + Placebo

Patients continued ARV's plus a placebo nightly for 9 months

DRUGNaltrexone

Naltrexone, Low-Dose (3mg) given once daily at bedtime for 9 months

DRUGNaltrexone + ARV's

Patients were given standard ARV's plus Naltrexone (Low Dose) 3mg nightly.

Sponsors

The Ojai Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* HIV-1 infected * CD4 count over 350 (arm 1/group 1) * CD4 count over 200 and on ARV's (arms 2,3/groups 2,3) * Age between 18 & 60 * Males or females

Exclusion criteria

* HIV-1 seronegative * HIV-2 infected * CD4 count lower than 200 * patients under age 18 * Those refusing to be in study * Pregnant or breast-feeding women * Patients under immuno-suppressor therapy * Those with renal or hepatic dysfunction * Malaria or tuberculosis

Design outcomes

Primary

MeasureTime frameDescription
CD4+ percentage (change in HIV-1 seropositive patients)9 MONTHSHIV+ 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).

Secondary

MeasureTime frameDescription
Clinical assessment of evidence of AIDS or other serious illness9 MONTHSHIV+ 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).

Countries

Mali

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026