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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Ojai Foundation
• Treatments: Efavirenz; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine; Lopinavir; Naltrexone; Nevirapine; Stavudine; Stavudine, lamivudine, nevirapine drug combination; Tenofovir

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