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

NCT ID: NCT01174914

Last Updated: 2010-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2010-03-31

Brief 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.

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.

Conditions

HIV Seropositivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Naltrexone + ARV's

Intervention Type: DRUG

Patients were given standard ARV's plus Naltrexone (Low Dose) 3mg nightly.

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.

Group Type: PLACEBO_COMPARATOR

ARV's + Placebo

Intervention Type: OTHER

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

Interventions

ARV's + Placebo

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

Intervention Type: OTHER

Naltrexone

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

Intervention Type: DRUG

Naltrexone + ARV's

Patients were given standard ARV's plus Naltrexone (Low Dose) 3mg nightly.

Intervention Type: DRUG

Other Intervention Names

Azidothimidine + lamivudine + nevirapine Or; Stavudine + lamivudine + nevirapine (TRIOMUNE)Or; Azidothimidine + lamivudine + efavirenz Or; Azidothimidine + lamivudine + lopinavir/r Or; Emtricitabine + tenofovir + efavirenz; Azidothimidine + lamivudine + nevirapine Or; Stavudine + lamivudine + nevirapine (TRIOMUNE)Or; Azidothimidine + lamivudine + efavirenz Or; Azidothimidine + lamivudine + lopinavir/r Or; Emtricitabine + tenofovir + efavirenz

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Ojai Foundation

OTHER

Sponsor Role: lead

Responsible Party

University of Bamako (Mali) Medical School

Principal Investigators

Abdel K Traore, MD

Role: PRINCIPAL_INVESTIGATOR

Professor, Bamako University School of Medicine

Locations

University Hospital of Point G

Bamako, , Mali

Countries

Mali

Other Identifiers

TOFLDNMALIHIVb

Identifier Type: -

Identifier Source: org_study_id