HIV Seropositivity
Conditions
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.
Interventions
Patients continued ARV's plus a placebo nightly for 9 months
Naltrexone, Low-Dose (3mg) given once daily at bedtime for 9 months
Patients were given standard ARV's plus Naltrexone (Low Dose) 3mg nightly.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CD4+ percentage (change in HIV-1 seropositive patients) | 9 MONTHS | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical assessment of evidence of AIDS or other serious illness | 9 MONTHS | 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). |
Countries
Mali