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

NCT01174914 | Completed Phase 2 DMC

• 1 other identifier: TOFLDNMALIHIVb
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Seropositivity

Outcome Measures

Primary Outcomes (1)

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

  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).

  9 MONTHS

Secondary Outcomes (1)

• Clinical assessment of evidence of AIDS or other serious illness

  9 MONTHS

Study Arms (3)

Naltrexone Low-dose 3mg capsule

EXPERIMENTAL

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 + ARVs

ACTIVE COMPARATOR

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

ARV's (continued,standard) plus Placebo

PLACEBO COMPARATOR

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

Interventions

ARV's + Placebo OTHER

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

Also known as: Azidothimidine + lamivudine + nevirapine Or, Stavudine + lamivudine + nevirapine (TRIOMUNE)Or, Azidothimidine + lamivudine + efavirenz Or, Azidothimidine + lamivudine + lopinavir/r Or, Emtricitabine + tenofovir + efavirenz

ARV's (continued,standard) plus Placebo

Naltrexone DRUG

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

Naltrexone Low-dose 3mg capsule

Naltrexone + ARV's DRUG

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

Also known as: Azidothimidine + lamivudine + nevirapine Or, Stavudine + lamivudine + nevirapine (TRIOMUNE)Or, Azidothimidine + lamivudine + efavirenz Or, Azidothimidine + lamivudine + lopinavir/r Or, Emtricitabine + tenofovir + efavirenz

Naltrexone Low Dose + ARVs

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Ojai Foundation: lead

Study Sites (1)

University Hospital of Point G

Bamako, BP0 Box 333, Mali

Location

MeSH Terms

Conditions

HIV Seropositivity

Interventions

Lamivudine; Nevirapine; Stavudine; stavudine, lamivudine, nevirapine drug combination; efavirenz; Emtricitabine; Tenofovir; Naltrexone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Pyridines; Thymidine; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Abdel K Traore, MD

  Professor, Bamako University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 4, 2010
• Study Start: March 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 4, 2010

Record last verified: 2010-08

Locations

MA (1)