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

The Ojai Foundation

Status and phase: Completed; Phase 2

Conditions: HIV Seropositivity

Treatments: Drug: Naltrexone; Other: ARV's + Placebo; Drug: Naltrexone + ARV's

Study type: Interventional

Funder types: Other

Identifiers

NCT01174914

TOFLDNMALIHIVb

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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171 participants in 3 patient groups, including a placebo group

Naltrexone Low-dose 3mg capsule

Experimental group

Description:

Each person in this arm 1 of the study had never received any ARV drugs and in this study received only one Low-Dose Naltrexone 3mg capsule nightly for 9 months (no placebo).

Treatment:

Drug: Naltrexone

Naltrexone Low Dose + ARVs

Active Comparator group

Description:

In this Arm 3, Patients were on ARV's plus being given Naltrexone Low-Dose (3mg) once daily at bedtime for 9 months.

Treatment:

Drug: Naltrexone + ARV's

ARV's (continued,standard) plus Placebo

Placebo Comparator group

Description:

In this arm 2, patients were started or continued on their standard ARV drugs plus placebo capsule once daily at bedtime; in the 2nd and 3rd arms patients did not know whether they were taking Low-Dose Naltrexone or a placebo.

Treatment:

Other: ARV's + Placebo