Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-23 @ 2:22 AM
Study NCT ID:
NCT01410058
Status:
COMPLETED
Last Update Posted:
2019-04-02
First Post:
2011-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C093273', 'term': 'flocculant protein MO 2.1, Moringa oleifera'}, {'id': 'C098320', 'term': 'efavirenz'}, {'id': 'D019829', 'term': 'Nevirapine'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'moneratg@yahoo.co.uk', 'phone': '307148', 'title': 'Tsitsi G Monera-Penduka', 'organization': 'University of Zimbabwe College of Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected at baseline (day 22) and at final visit (day 35).', 'description': 'All participants were monitored for adverse events throughout the study. The study medical officer documented any adverse events observed from clinical examinations or self-reported by the participants at each of the two visits. Urinalysis and Serum biochemistries were determined and graded based on CTCAE.', 'eventGroups': [{'id': 'EG000', 'title': 'Nevirapine', 'description': 'HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder\n\nMoringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 4, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Efavirenz', 'description': 'HIV positive patients on efavirenz containing regimen, taking Moringa oleifera\n\nMoringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Altered creatinine clearance', 'notes': 'Creatinine clearance outside range 88-137 mL/min', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Elevated liver transaminase', 'notes': 'greater than upper limit of normal - 3 times upper limit of normal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nevirapine', 'description': 'HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder\n\nMoringa oleifera: leaf powder'}, {'id': 'OG001', 'title': 'Efavirenz', 'description': 'HIV positive patients on efavirenz containing regimen, taking Moringa oleifera\n\nMoringa oleifera: leaf powder'}], 'classes': [{'title': 'Baseline (Day 22)', 'categories': [{'measurements': [{'value': '94.17', 'spread': '25.24', 'groupId': 'OG000'}, {'value': '34.67', 'spread': '24.85', 'groupId': 'OG001'}]}]}, {'title': 'Post-moringa (Day 35)', 'categories': [{'measurements': [{'value': '100.44', 'spread': '27.65', 'groupId': 'OG000'}, {'value': '32.58', 'spread': '38.75', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (day 22), Post-moringa (day 35)', 'description': 'Area under the plasma concentration time curve, determined using a non-compartmental approach by means of the Phoenix WinNonlin software application. Time points for sample collection were 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h', 'unitOfMeasure': 'h*microgram/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with complete data were included'}, {'type': 'SECONDARY', 'title': 'C12h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nevirapine', 'description': 'HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder\n\nMoringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules'}, {'id': 'OG001', 'title': 'Efavirenz', 'description': 'HIV positive patients on efavirenz containing regimen, taking Moringa oleifera\n\nMoringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules'}], 'classes': [{'title': 'Baseline (Day 22)', 'categories': [{'measurements': [{'value': '7.30', 'spread': '25.85', 'groupId': 'OG000'}, {'value': '2.96', 'spread': '18.75', 'groupId': 'OG001'}]}]}, {'title': 'Post-moringa (Day 35)', 'categories': [{'measurements': [{'value': '7.55', 'spread': '28.56', 'groupId': 'OG000'}, {'value': '2.53', 'spread': '21.35', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (Day 22); Post-moringa (Day 35)', 'description': 'plasma concentration 12h post dose, determined using a non-compartmental approach by means of the Phoenix WinNonlin software application. Time points for sample collection were 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h', 'unitOfMeasure': 'microgram/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with complete data were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nevirapine', 'description': 'HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder\n\nMoringa oleifera: leaf powder'}, {'id': 'OG001', 'title': 'Efavirenz', 'description': 'HIV positive patients on efavirenz containing regimen, taking Moringa oleifera\n\nMoringa oleifera: leaf powder'}], 'classes': [{'title': 'Baseline (Day 22)', 'categories': [{'measurements': [{'value': '9.92', 'spread': '26.93', 'groupId': 'OG000'}, {'value': '5.08', 'spread': '22.95', 'groupId': 'OG001'}]}]}, {'title': 'Post-moringa (Day 35)', 'categories': [{'measurements': [{'value': '10.57', 'spread': '29.62', 'groupId': 'OG000'}, {'value': '5.51', 'spread': '38.28', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (day 22), Post-moringa (day 35)', 'description': 'Maximum plasma concentration post does, determined using a non-compartmental approach by means of the Phoenix WinNonlin software application. Time points for sample collection were 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h', 'unitOfMeasure': 'microgram/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with complete data were included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nevirapine', 'description': 'HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder'}, {'id': 'FG001', 'title': 'Efavirenz', 'description': 'HIV positive patients on efavirenz containing regimen, taking Moringa oleifera leaf powder'}], 'periods': [{'title': 'Washout Day 0', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Baseline Day 22', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Day 35', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'HIV-infected male and female adults reporting for routine HIV clinic visits at a referral hospital in Zimbabwe were identified through an interviewer-administered questionnaire.', 'preAssignmentDetails': 'The study had a minimum 3-week herbal medication wash out period prior to the first dosing to reduce the possibility of carryover from any type of previously used moringa or other herbal medication, so the participants would have the same baseline.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nevirapine', 'description': 'HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder\n\nMoringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules'}, {'id': 'BG001', 'title': 'Efavirenz', 'description': 'HIV positive patients on efavirenz containing regimen, taking Moringa oleifera\n\nMoringa oleifera: leaf powder, 1.85g once daily as hard gelatin capsules'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '8', 'groupId': 'BG000'}, {'value': '43', 'spread': '8', 'groupId': 'BG001'}, {'value': '44', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '72.5', 'spread': '17.0', 'groupId': 'BG001'}, {'value': '65.9', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': '11/13 were analysed in the nevirapine arm. 2 had missing data due to insufficient blood sample and were excluded from analysis.\n\n6/6 were analysed for efavirenz arm'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, plasma, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-29', 'studyFirstSubmitDate': '2011-08-03', 'resultsFirstSubmitDate': '2017-08-23', 'studyFirstSubmitQcDate': '2011-08-03', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-29', 'studyFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Baseline (day 22), Post-moringa (day 35)', 'description': 'Maximum plasma concentration post does, determined using a non-compartmental approach by means of the Phoenix WinNonlin software application. Time points for sample collection were 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h'}], 'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': 'Baseline (day 22), Post-moringa (day 35)', 'description': 'Area under the plasma concentration time curve, determined using a non-compartmental approach by means of the Phoenix WinNonlin software application. Time points for sample collection were 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h'}], 'secondaryOutcomes': [{'measure': 'C12h', 'timeFrame': 'Baseline (Day 22); Post-moringa (Day 35)', 'description': 'plasma concentration 12h post dose, determined using a non-compartmental approach by means of the Phoenix WinNonlin software application. Time points for sample collection were 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'antiretroviral drug interaction', 'herbal medicine', 'pharmacokinetics', 'herbal pharmacology'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '17089328', 'type': 'BACKGROUND', 'citation': 'Anwar F, Latif S, Ashraf M, Gilani AH. Moringa oleifera: a food plant with multiple medicinal uses. Phytother Res. 2007 Jan;21(1):17-25. doi: 10.1002/ptr.2023.'}, {'pmid': '11317592', 'type': 'BACKGROUND', 'citation': 'Sebit MB, Chandiwana SK, Latif AS, Gomo E, Acuda SW, Makoni F, Vushe J. Quality of life evaluation in patients with HIV-I infection: the impact of traditional medicine in Zimbabwe. Cent Afr J Med. 2000 Aug;46(8):208-13.'}, {'pmid': '16877262', 'type': 'BACKGROUND', 'citation': 'van den Bout-van den Beukel CJ, Koopmans PP, van der Ven AJ, De Smet PA, Burger DM. Possible drug-metabolism interactions of medicinal herbs with antiretroviral agents. Drug Metab Rev. 2006;38(3):477-514. doi: 10.1080/03602530600754065.'}, {'pmid': '28293270', 'type': 'DERIVED', 'citation': 'Monera-Penduka TG, Maponga CC, Wolfe AR, Wiesner L, Morse GD, Nhachi CF. Effect of Moringa oleifera Lam. leaf powder on the pharmacokinetics of nevirapine in HIV-infected adults: a one sequence cross-over study. AIDS Res Ther. 2017 Mar 14;14:12. doi: 10.1186/s12981-017-0140-4. eCollection 2017.'}, {'pmid': '28250958', 'type': 'DERIVED', 'citation': 'Monera-Penduka TG, Maponga CC, Morse GD, Nhachi CFB. Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients. J Pharm Policy Pract. 2017 Feb 20;10:9. doi: 10.1186/s40545-017-0099-5. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'A study will be conducted by scientists from the University of Zimbabwe to determine if antiretroviral drugs are affected by taking herbs at the same time. This is important because herbal medicines may interact with modern medicine to increase or decrease the amount of medication in the body.\n\nThe drugs nevirapine and efavirenz will be studied. Both drugs are routinely used as part of combination therapy for treating HIV. In this study it will be determined whether the concentrations of the antiretroviral drugs nevirapine and efavirenz are low, high or are in the desired range when taken together with the herb moringa.', 'detailedDescription': "The use of herbal supplements is widespread in Africa, particularly for the management of HIV and AIDS. In Zimbabwe, the prevalence of herbal medicine use in HIV-infected people is as high as 79% (Sebit et al., 2000). Several studies have shown that the herb Moringa oleifera is among the top 10 herbs most commonly used by HIV-positive people in Zimbabwe (Makomeya et al 2004, Monera et al 2008). Another review also cited Moringa as one of the 53 most important African medicinal plants presently traded (van den Bout-van den Beukel et al 2006). Others included Hypoxis hemerocallidea (African potato) and Sutherlandia frutescens-(Cancer bush). Moringa is rich in β-carotene, protein, vitamin C, calcium and potassium and act as a good source of natural antioxidants (Anwar et al.,2007).It is recommended by non-governmental organisations and some African governments as an immune booster and a nutritional supplement for people living with HIV and AIDS (Ncube, 2006). Most advocates and users believe that since the herb is natural, it is free from all side effects and interactions.\n\nConcomitant use of herbs with conventional drugs may lead to herb-drug interactions in the same way that two or more co-administered drugs may interact. Herbal constituents that are substrates for the same enzymes or transporters of conventional drugs may induce or inhibit the enzymes and/or transporter activity. Pharmacokinetic endpoints such as area under the curve (AUC), time to maximum plasma concentration (tmax), peak plasma concentration (Cmax), trough concentration (Cmin), clearance (CL), volume of distribution (Vd/F) and half-life (T1/2) may be altered significantly resulting in toxicity, more severe adverse effects, sub-therapeutic drug concentrations, HIV resistance and treatment failure.The risk of interaction increases as the number of co-administered drugs increases (de Maat et al 2003). As a result, people taking herbal medicines while on antiretroviral therapy are at very high risk because of the multitude use of highly active antiretroviral drugs and treatment of opportunistic infections, and also because herbs contain a wide range of bioactive chemical constituents.\n\nHowever, evidence based information of such effects is usually lacking and as such; health practitioners' ability to make relevant clinical decisions is limited. Results of a review of in vitro studies suggest a need for in vivo metabolic drug-drug interaction studies (van den Bout-van den Beukel et al 2006). Preliminary in vivo studies in animal models can serve as a basis for clinical trials, the results of which are considered the gold standard in this era of evidence-based medicine.\n\nPrimary objectives\n\n1. To compare the steady-state pharmacokinetics of nevirapine and efavirenz in HIV-positive patients before and after supplementation with Moringa oleifera leaf powder\n2. To compare the single dose pharmacokinetics of nevirapine and efavirenz in rat models before and after supplementation with Moringa oleifera leaf powder\n\n Secondary objectives\n3. To determine the bioavailability of Moringa oleifera leaf powder in humans after oral dosing using beta carotene as a bio marker.\n4. To compare urine chemistries and liver function tests in HIV patients before and after supplementation with Moringa oleifera leaf powder\n5. To determine the presence of any genetic variation in the participants in the genes that code for CYP3A4 and CYP2B6"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'HIV Opportunistic infections clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV positive,\n* ≥ 4 weeks on Nevirapine or , ≥ 2 weeks on Efavirenz containing regimen,\n* Supplements HAART with Moringa oleifera.\n\nExclusion Criteria:\n\nKnown hepatic, intestinal or renal disease,smoking, chronic alcohol ingestion, poor venous access, chronic alcohol ingestion, pregnant, smoking, on rifampicin, ketoconazole, isoniazid, breastfeeding, anaemia,vomiting'}, 'identificationModule': {'nctId': 'NCT01410058', 'briefTitle': 'Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction', 'organization': {'class': 'OTHER', 'fullName': 'University of Zimbabwe'}, 'officialTitle': 'Effect of Moringa Oleifera (Moringa, Drumstick/Horseradish Tree) on The Pharmacokinetics of Efavirenz and Nevirapine In-vivo.', 'orgStudyIdInfo': {'id': 'MO 001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nevirapine', 'description': 'HIV positive patients on nevirapine containing regimen, taking Moringa oleifera leaf powder', 'interventionNames': ['Dietary Supplement: Moringa oleifera', 'Drug: Nevirapine 200Mg Oral Tablet']}, {'label': 'Efavirenz', 'description': 'HIV positive patients on efavirenz containing regimen, taking Moringa oleifera', 'interventionNames': ['Dietary Supplement: Moringa oleifera', 'Drug: Efavirenz 600mg']}], 'interventions': [{'name': 'Moringa oleifera', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['moringa', 'drumstick tree', 'horseradish tree'], 'description': 'leaf powder, 1.85g once daily, hard gelatin capsules', 'armGroupLabels': ['Efavirenz', 'Nevirapine']}, {'name': 'Efavirenz 600mg', 'type': 'DRUG', 'description': 'Efavirenz 600mg based regimen', 'armGroupLabels': ['Efavirenz']}, {'name': 'Nevirapine 200Mg Oral Tablet', 'type': 'DRUG', 'description': 'Nevirapine 200mg based regimen', 'armGroupLabels': ['Nevirapine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'Parirenyatwa Hospital OI Clinic', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'Tsitsi G Monera, BPharmHons, MPhil, MSc CT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zimbabwe'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zimbabwe', 'class': 'OTHER'}, 'collaborators': [{'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, {'name': 'Biomedical Research and Training Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Tsitsi Grace Monera', 'investigatorAffiliation': 'University of Zimbabwe'}}}}