Effectiveness Study Low-Dose Naltrexone Versus ARV's for HIV+
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Seropositivity |
Other: ARV's + Placebo Drug: Naltrexone Drug: Naltrexone + ARV's |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression |
- CD4+ percentage (change in HIV-1 seropositive patients) [ Time Frame: 9 MONTHS ] [ Designated as safety issue: No ]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).
- Clinical assessment of evidence of AIDS or other serious illness [ Time Frame: 9 MONTHS ] [ Designated as safety issue: No ]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).
| Enrollment: | 171 |
| Study Start Date: | March 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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).
|
Drug: Naltrexone
Naltrexone, Low-Dose (3mg) given once daily at bedtime for 9 months
|
|
Active Comparator: 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.
|
Drug: Naltrexone + ARV's
Patients were given standard ARV's plus Naltrexone (Low Dose) 3mg nightly.
Other Names:
|
|
Placebo Comparator: 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.
|
Other: ARV's + Placebo
Patients continued ARV's plus a placebo nightly for 9 months
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Mali | |
| University Hospital of Point G | |
| Bamako, Mali, BP0 Box 333 | |
| Principal Investigator: | Abdel K Traore, MD | Professor, Bamako University School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Abdel Kader Traore, MD, PI, Professor Bamako University School of Medicine, Pharmacy and Odontostomatology, University of Bamako (Mali) Medical School |
| ClinicalTrials.gov Identifier: | NCT01174914 History of Changes |
| Other Study ID Numbers: | TOFLDNMALIHIVb |
| Study First Received: | August 2, 2010 |
| Last Updated: | August 2, 2010 |
| Health Authority: | Mali: Ministry of Health |
Additional relevant MeSH terms:
|
HIV Seropositivity HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Naltrexone Nevirapine Stavudine Lamivudine Tenofovir |
Efavirenz Lopinavir Emtricitabine Narcotic Antagonists Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013