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).
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|