Effectiveness Study Low-Dose Naltrexone Versus ARV's for HIV+
|ClinicalTrials.gov Identifier: NCT01174914|
Recruitment Status : Completed
First Posted : August 4, 2010
Last Update Posted : August 4, 2010
|Condition or disease||Intervention/treatment||Phase|
|HIV Seropositivity||Other: ARV's + Placebo Drug: Naltrexone Drug: Naltrexone + ARV's||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||171 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
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).
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.
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
- 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).
- Clinical assessment of evidence of AIDS or other serious illness [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174914
|University Hospital of Point G|
|Bamako, Mali, BP0 Box 333|
|Principal Investigator:||Abdel K Traore, MD||Professor, Bamako University School of Medicine|