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

This study has been completed.
Sponsor:
Information provided by:
The Ojai Foundation
ClinicalTrials.gov Identifier:
NCT01174914
First received: August 2, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted

August 2, 2010
August 2, 2010
March 2008
March 2010   (final data collection date for primary outcome measure)
CD4+ percentage (change in HIV-1 seropositive patients) [ Time Frame: 9 MONTHS ] [ Designated as safety issue: No ]
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).
Same as current
No Changes Posted
Clinical assessment of evidence of AIDS or other serious illness [ Time Frame: 9 MONTHS ] [ Designated as safety issue: No ]
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).
Same as current
Not Provided
Not Provided
 
Effectiveness Study Low-Dose Naltrexone Versus ARV's for HIV+
Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
HIV Seropositivity
  • Other: ARV's + Placebo
    Patients continued ARV's plus a placebo nightly for 9 months
    Other Names:
    • Azidothimidine + lamivudine + nevirapine Or
    • Stavudine + lamivudine + nevirapine (TRIOMUNE)Or
    • Azidothimidine + lamivudine + efavirenz Or
    • Azidothimidine + lamivudine + lopinavir/r Or
    • Emtricitabine + tenofovir + efavirenz
  • 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
  • Experimental: Naltrexone Low-dose 3mg capsule
    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).
    Intervention: Drug: Naltrexone
  • Active Comparator: Naltrexone Low Dose + ARVs
    In this Arm 3, Patients were on ARV's plus being given Naltrexone Low-Dose (3mg) once daily at bedtime for 9 months.
    Intervention: Drug: Naltrexone + ARV's
  • Placebo Comparator: ARV's (continued,standard) plus Placebo
    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.
    Intervention: Other: ARV's + Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Mali
 
NCT01174914
TOFLDNMALIHIVb
Yes
Abdel Kader Traore, MD, PI, Professor Bamako University School of Medicine, Pharmacy and Odontostomatology, University of Bamako (Mali) Medical School
The Ojai Foundation
Not Provided
Principal Investigator: Abdel K Traore, MD Professor, Bamako University School of Medicine
The Ojai Foundation
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP