HIV SeropositivityPhase 2NCT01174914
Effectiveness Study Low-Dose Naltrexone Versus ARV's for HIV+
A Phase 2 study testing Naltrexone and Naltrexone + ARV's in people with HIV Seropositivity, run by The Ojai Foundation at 1 site in Mali.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Seropositivity
- What is being tested?
- Naltrexone and Naltrexone + ARV's
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteMali
- Study dates
- Mar 2008to Mar 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- Patients under immuno-suppressor therapy
- Those with renal or hepatic dysfunction
- Malaria or tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression
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.
Read the 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.
- Conditions
- HIV Seropositivity
- Being tested
- ARV's + Placebo, Naltrexone, Naltrexone + ARV's
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARV's + PlaceboOther
Also called Azidothimidine + lamivudine + nevirapine Or, Stavudine + lamivudine + nevirapine (TRIOMUNE)Or, Azidothimidine + lamivudine + efavirenz Or, Azidothimidine + lamivudine + lopinavir/r Or
Patients continued ARV's plus a placebo nightly for 9 months
NaltrexoneDrug
Naltrexone, Low-Dose (3mg) given once daily at bedtime for 9 months
Naltrexone + ARV'sDrug
Also called Azidothimidine + lamivudine + nevirapine Or, Stavudine + lamivudine + nevirapine (TRIOMUNE)Or, Azidothimidine + lamivudine + efavirenz Or, Azidothimidine + lamivudine + lopinavir/r Or
Patients were given standard ARV's plus Naltrexone (Low Dose) 3mg nightly.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Other: ARV's + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 9 MONTHS
Secondary outcomes (1)
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).
Measured: 9 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startMar 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Ojai Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Abdel K Traore, MD, Principal investigator, Professor, Bamako University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174914
- Sponsor's protocol ID
- TOFLDNMALIHIVb
- Status last verified
- Aug 2010
- First submitted
- 2 Aug 2010
- Last updated
- 4 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression
- ClinicalTrials.gov ID
- NCT01174914
- Acronym / sponsor ID
- TOFLDNMALIHIVb
- Conditions
- HIV Seropositivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- The Ojai FoundationUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 4 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Naltrexone Low-dose 3mg capsule | Experimental | Drug: NaltrexoneEach 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). |
| Naltrexone Low Dose + ARVs | Active comparator | Drug: Naltrexone + ARV'sIn this Arm 3, Patients were on ARV's plus being given Naltrexone Low-Dose (3mg) once daily at bedtime for 9 months. |
| ARV's (continued,standard) plus Placebo | Placebo comparator | Other: ARV's + PlaceboIn 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- HIV-1 seronegative
- HIV-2 infected
- CD4 count lower than 200
- patients under age 18
- Those refusing to be in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARV's + PlaceboAlso: Azidothimidine + lamivudine + nevirapine Or, Stavudine + lamivudine + nevirapine (TRIOMUNE)Or, Azidothimidine + lamivudine + efavirenz Or, Azidothimidine + lamivudine + lopinavir/r OrPatients continued ARV's plus a placebo nightly for 9 months | Other | ARV's (continued,standard) plus Placebo |
| NaltrexoneNaltrexone, Low-Dose (3mg) given once daily at bedtime for 9 months | Drug | Naltrexone Low-dose 3mg capsule |
| Naltrexone + ARV'sAlso: Azidothimidine + lamivudine + nevirapine Or, Stavudine + lamivudine + nevirapine (TRIOMUNE)Or, Azidothimidine + lamivudine + efavirenz Or, Azidothimidine + lamivudine + lopinavir/r OrPatients were given standard ARV's plus Naltrexone (Low Dose) 3mg nightly. | Drug | Naltrexone Low Dose + ARVs |
Primary outcome
CD4+ percentage (change in HIV-1 seropositive patients)
Time frame: 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).
1 secondary outcome
Clinical assessment of evidence of AIDS or other serious illness
Time frame: 9 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdel K Traore, MD principal investigator
Professor, Bamako University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone and Naltrexone + ARV's in people with HIV Seropositivity, run by The Ojai Foundation at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD4+ percentage (change in HIV-1 seropositive patients) (time frame: 9 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2010.