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
  Purpose

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.


Condition Intervention Phase
HIV Seropositivity
Other: ARV's + Placebo
Drug: Naltrexone
Drug: Naltrexone + ARV's
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression

Resource links provided by NLM:


Further study details as provided by The Ojai Foundation:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 171
Study Start Date: March 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Drug: Naltrexone
Naltrexone, Low-Dose (3mg) given once daily at bedtime for 9 months
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.
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174914

Locations
Mali
University Hospital of Point G
Bamako, Mali, BP0 Box 333
Sponsors and Collaborators
The Ojai Foundation
Investigators
Principal Investigator: Abdel K Traore, MD Professor, Bamako University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Abdel Kader Traore, MD, PI, Professor Bamako University School of Medicine, Pharmacy and Odontostomatology, University of Bamako (Mali) Medical School
ClinicalTrials.gov Identifier: NCT01174914     History of Changes
Other Study ID Numbers: TOFLDNMALIHIVb
Study First Received: August 2, 2010
Last Updated: August 2, 2010
Health Authority: Mali: Ministry of Health

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Naltrexone
Nevirapine
Stavudine
Lamivudine
Tenofovir
Efavirenz
Lopinavir
Emtricitabine
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on July 31, 2014