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

NCT01174914 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2010-08-04

No results posted yet for this study

Summary

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.

Conditions

  • HIV Seropositivity

Interventions

OTHER

ARV's + Placebo

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

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.

Sponsors & Collaborators

  • The Ojai Foundation

    lead OTHER

Principal Investigators

  • Abdel K Traore, MD · Professor, Bamako University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Mali

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01174914 on ClinicalTrials.gov