Skip to main content
OpenTrials
Completed

NCT Number: NCT01174914

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Seropositivity Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital of Point G

Bamako, BP0 Box 333, Mali

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARV's + Placebo

Other

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

Naltrexone

Drug

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

Naltrexone + ARV's

Drug

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

Primary outcomes

  1. CD4+ percentage (change in HIV-1 seropositive patients)

    Time frame: 9 MONTHS

    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 outcomes

  1. Clinical assessment of evidence of AIDS or other serious illness

    Time frame: 9 MONTHS

    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).

Sponsors and collaborators

Lead sponsor

The Ojai Foundation

Other

Registry information

Official study title

Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 4, 2010
Registry last updated
Aug 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.