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

HIV Seropositivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174914
• Other study ID #: TOFLDNMALIHIVb
• Status: Completed
• Phase: Phase 2
• First received: August 2, 2010
• Last updated: August 2, 2010
• Start date: March 2008
• Est. completion date: March 2010

Study information

• Verified date: August 2010
• Source: The Ojai Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mali: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Seropositivity

Intervention

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

Locations

Country	Name	City	State
Mali	University Hospital of Point G	Bamako

Sponsors (1)

Lead Sponsor	Collaborator
The Ojai Foundation

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical assessment of evidence of AIDS or other serious illness	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).	9 MONTHS	No

External Links

•   Describes this clinical research study just completed in Mali to compare effectiveness of drug intervention LDN with standard ARV's.