Trial | NCT01174914  Report issue

Title

Effectiveness Study Low-Dose Naltrexone Versus ARV's for HIV+
Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    171
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.
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.
Study Started
Mar 31
2008
Primary Completion
Mar 31
2010
Study Completion
Mar 31
2010
Last Update
Aug 04
2010
Estimate

Other ARV's + Placebo

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

  • Other names: Emtricitabine + tenofovir + efavirenz, Azidothimidine + lamivudine + nevirapine Or, Stavudine + lamivudine + nevirapine (TRIOMUNE)Or, Azidothimidine + lamivudine + efavirenz Or, Azidothimidine + lamivudine + lopinavir/r Or

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.

  • Other names: Azidothimidine + lamivudine + nevirapine Or, Stavudine + lamivudine + nevirapine (TRIOMUNE)Or, Azidothimidine + lamivudine + efavirenz Or, Azidothimidine + lamivudine + lopinavir/r Or, Emtricitabine + tenofovir + efavirenz

Naltrexone Low-dose 3mg capsule Experimental

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).

Naltrexone Low Dose + ARVs Active Comparator

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

ARV's (continued,standard) plus Placebo Placebo Comparator

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.

Criteria 

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
No Results Posted