Research by Network

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A5264

Current Study

A Randomized Evaluation of Antiretroviral Therapy Alone or with Delayed Chemotherapy Versus Antiretroviral Therapy with Immediate Adjunctive Chemotherapy for Treatment of Limited Stage AIDS-KS in Resource Limited Settings Sponsors: US National Institut …

ACTG

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A5263

Current Study

A Randomized Comparison of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource Limited Settings Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) The National Canc …

ACTG

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MTN 015

Current Study

An Observational Cohort Study of Women following HIV-1 Seroconversion in Microbicide Trials Sponsors: Division of AIDS, US National Institute of Allergy and Infectious Diseases (NIAID) US National Institutes of Health (NIH) Protocol Summary: MTN-015 is …

MTN

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MTN 016

Current Study

(EMBRACE): HIV Prevention Agent Pregnancy Exposure Registry Sponsors: Division of AIDS, US National Institute of Allergy and Infectious Diseases (NIAID) US National Institutes of Health (NIH) Protocol Summary: EMBRACE is a prospective observational coh …

MTN

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Disclosure Intervention for Zimbabwean Parents

Current Study

Sponsor: US National Institutes of Health (NIH) Protocol Summary: 300 parents living with HIV (PLH) will be randomized into either an 1) experimental condition, a disclosure intervention or 2) attention control condition, a nutrition intervention. The …

Non-Network

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P1078

Current Study

A Phase IV Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety (Hepatotoxicity) of Immediate (Antepartum-Initiated) vs. Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-Infected Women in High TB incidence Set …

IMPAACT

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ZIM CHIC

Current Study

HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas Sponsor: Bill & Melinda Gates Foundation, through a grant from McMagee-Women’s Research Institute and Foundation, University of Pittsburg Protoco …

Non-Network

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HPTN 076

Current Study

Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278 LA, for Pre Exposure Prophylaxis (PrEP) Sponsors: Division of AIDS, US National Institute of Allergy and Infectious Diseases (NIAID) US National Institutes of Health (NI …

HPTN

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P1115

Current Study

Very Early Intensive Treatment of HIV-Infected Infants  to Achieve HIV Remission: A Phase I/II Proof-of-Concept Study Sponsors: The National Institute of Allergy and Infectious Diseases (NIAD) The Eunice Kennedy Shriver National Institute of Child Heal …

IMPAACT

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HVTN 703/HPTN 081 (AMP)

Current Study

A Phase 2b Study to Evaluate the Safety and Efficacy of VRC01 Broadly Neutralizing Monoclonal Antibody in Reducing Acquisition of HIV-1 Infection in Women in sub-Saharan Africa Sponsors: Division of AIDS (DAIDS) National Institute of Allergy and Infect …

HPTN

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HPTN 082

Current Study

Evaluation of Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study Sponsors: Division of AIDS (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Mental health (NIMH) Nationa …

HPTN

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MTN 025 (HOPE)

Current Study

A Phase 3B Open-Label Follow-on Trial to Assess the Continued Safety and Adherence to a Vaginal Ring Containing Dapivirine in Women (HOPE) Sponsors: Division of AIDS (DAIDS) Eunice Kennedy Shriver National Institute of Child Health and Development (NIC …

MTN

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MTN 032

Current Study

Assessment of ASPIRE and HOPE Adherence Sponsors: Division of AIDS (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Menta …

MTN

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A5175

Completed Study

A Phase IV, Prospective, Randomized, Open-Label Evaluation of the Efficacy of Once-Daily PI & Once-Daily Non-NRTI – Containing Therapy Combinations for Initial Treatment of HIV-1 Infected individuals from Resource – Limited Settings (PEARLS) Trial …

ACTG

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A5199

Completed Study

International Neuropsychological Assessment of Patients Initiating Antiretroviral Therapy in Resource-Limited Settings Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) US National Institute of Mental Health Summary: A5199 was …

ACTG

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HIVNET/HPTN 016A

Completed Study

Condom Promotion and Counseling Sponsor: US National Institutes of Health (NIH) Protocol Summary: The aim of the study was to evaluate the effectiveness of condom promotion and counseling messages on uptake of condoms as a means to prevent HIV transmis …

HPTN

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HIVNET/HPTN 016A Substudy

Completed Study

Association of Sexually Transmitted Infections and HIV Among Women Attending the Condom Promotion and Counseling Study in Harare Sponsor: US National Institutes of Health (NIH) Protocol Summary: The aim of this substudy was to compare the prevalence of …

HPTN

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A5190/P1054

Completed Study

Assessment of Safety and Toxicity among Infants Born To HIV-1-Infected Women Enrolled in Antiretroviral Treatment Protocols in Diverse Areas of the World Sponsor: US National Institute of Allergy and Infectious Diseases (NIAID) Protocol Summary: A5190- …

ACTG

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A5199

Completed Study

International Neuropsychological Assessment of Patients Initiating Antiretroviral Therapy in Resource-Limited Settings Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) US National Institute of Mental Health Summary: A5199 was …

ACTG

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A5208

Completed Study

Optimal Combination Therapy After Nevirapine Exposure (OCTANE) Sponsor: US National Institute of Allergy and Infectious Diseases (NIAID) Protocol Summary: A5208 was a phase III study that comprised of two randomized clinical trials that were conducted …

ACTG

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A5221

Completed Study

A Strategy Study of Immediate Versus Deferred initiation of Antiretroviral Therapy for AIDS Disease-Free Survival in HIV-Infected Persons Treated for Tuberculosis with CD4 Sponsor: US National Institute of Allergy and Infectious Diseases (NIAID) Protoc …

ACTG

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A5225

Completed Study

A Phase I/II Dose-Finding Study of High-Dose Fluconazole Treatment in AIDS-Associated Cryptococcal Meningitis Sponsor: US National Institute of Allergy and Infectious Diseases (NIAID) Protocol Summary: A5225 was a phase I/II dose escalation and validat …

ACTG

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A5234

Completed Study

International Trial of Modified Directly Observed Therapy versus Self-Administered Therapy for Participants with First Virologic Failure on a Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Antiretroviral Regimen Sponsor: US National Institut …

ACTG

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HIVNET/HPTN 023

Completed Study

Safety and Trough Concentrations of Nevirapine Prophylaxis Given Daily, Twice Weekly, or Weekly in Breast-Feeding Infants from Birth to 6 Months Sponsor: US National Institutes of Health (NIH) Protocol Summary: HIVNET 023 was a phase I/II, open-label, …

HPTN

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HPTN 039

Completed Study

A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Acyclovir for the Reduction of HIV Acquisition Among High Risk HSV-2 Seropositive, HIV Seronegative Individuals Sponsors: Division of AIDS, US National Institute of Allergy and Infectio …

HPTN

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HPTN 043

Completed Study

A Phase III, Randomized, Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Post-Testing Support for HIV in Sub-Saharan Africa and Thailand (Project Accept) Sponsor: US National Institute of Mental Health Protocol Summary …

HPTN

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HPTN/IMPAACT 046

Completed Study

Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV Infected Women to Prevent Vertical HIV Transmission During Breastfeeding Sponsors: Division of AIDS, US National Institute of Allergy and I …

IMPAACT

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PEPFAR 046

Completed Study

Integrating Family Planning into PMTCT: A Novel Approach in Zimbabwe (A Substudy of HPTN/IMPAACT 046) Sponsors: US National Institutes of Health (NIH) PEPFAR Protocol Summary: PEPFAR 046 sought to understand the feasibility and short-term effects of an …

IMPAACT

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P1060

Completed Study

Phase II, Parallel, Randomized, Clinical Trials Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV-Infected Infants Who Have and Have Not Previously Received Single Dose Nevirapine for Prevention of Mothe …

IMPAACT

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Phase I Trial of the Topical Microbicide BufferGel

Completed Study

Sponsors: Division of AIDS, US National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) Protocol Summary: To evaluate the safety of BufferGel, a spermicidal microbicide that acidifies semen and maintains the pro …

MTN

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HPTN/MTN 035

Completed Study

Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO2000/5 Gel (P) for the Prevention of HIV Infection in Women Sponsors: Division of AIDS, US National Institute of Allergy and Infectious Diseases (NIAID) Natio …

MTN

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MTN 003 (VOICE)

Completed Study

Safety and effectiveness of Tenofovir 1% Gel,Tenofovir Disoproxil Fumarate Tablet and Emtricitabine/ Tenofovir Disoproxil Fumarate Tablet for the prevention of HIV infection in women Sponsors: Division of AIDS US National Institute of Allergy and Infec …

MTN

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Visual Inspection of the Cervix as a Primary Means of Cervical Cancer Screening: Results of a Pilot Study

Completed Study

Sponsor: US National Institutes of Health (NIH) Protocol Summary: The objective was to measure the effectiveness of unaided visual inspection (UVI) of the cervix as a primary means of cervical cancer screening. 1000 women attending primary health care …

Non-Network

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A Randomized, Controlled Safety Trial of the Diaphragm and Cellulose Sulfate Microbicide Gel in Sexually Active Women in Zimbabwe

Completed Study

Sponsor: CONRAD Protocol Summary: Cellulose sulfate (CS) was an antimicrobial and contraceptive agent. This study was designed with three arms: 1) diaphragm with 6% CS gel; 2) diaphragm with KY gel and; 3) CS gel alone. Participants were instructed to …

Non-Network

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Hormonal Contraception and the Risk of HIV-1 Acquisition Among Young Women in Uganda and Zimbabwe

Completed Study

Sponsors: US National Institutes of Health (NIH) Protocol Summary: Combined oral contraceptives (COC) and depot-medroxyprogesterone acetate (DMPA) are among the most widely used family planning methods; their effect on HIV acquisition is unknown. This …

Non-Network

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Oral Candidiasis Marker of HIV-Disease Progression Among Zimbabwean Women

Completed Study

Sponsor: US National Institutes of Health (NIH) Protocol Summary: To estimate oral disease prevalence among Zimbabwean women in relation to HIV serostatus and CD4 count, and to assess the agreement rate between oral soft tissue examination outcomes mea …

Non-Network

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Diaphragm and Lubricant Gel for Prevention of HIV Acquisition in Southern African Women: A Randomized, Controlled Trial (MIRA)

Completed Study

Sponsor: The Bill and Melinda Gates Foundation Protocol Summary: MIRA was a multi-site, randomized, controlled study that sought to measure the effectiveness of the diaphragm, Replens gel and condoms versus condoms alone in preventing heterosexual acq …

Non-Network

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The Reliability of ACASI Data Collection in Zimbabwe

Completed Study

Sponsor: US National Institutes of Health (NIH) Protocol Summary: Research on the measurement of HIV risk demonstrates that interview mode can affect reporting; however, few studies have applied these findings to assessment sof hormonal contraceptive u …

Non-Network

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Linking Alcohol Use with HIV Risk Behavior and HIV Prevalence Among Beer Hall Patrons in Harare, Zimbabwe

Completed Study

Sponsor: US National Institutes of Health (NIH) Protocol Summary: In Harare, beer halls are among the few affordable recreation venues for men in low to medium income neighborhoods. They are well attended and ubiquitous institutions serving men’s needs …

Non-Network

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An Acceptability and Safety Study of the Duet® Cervical Barrier and Gel Delivery System in Zimbabwe

Completed Study

Sponsors: US National Institutes of Health (NIH) The Bill & Belinda Gates Foundation Protocol Summary: Adherence problems with coitally dependent, female-initiated HIV prevention methods have contributed to several studies unable to establish effic …

Non-Network

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Establishment of Laboratory Reference Values for Harare, Chitungwiza, and Mutoko

Completed Study

Sponsor: US National Institutes of Health (NIH) Protocol Summary: This study sought to establish local reference values in order to enable accurate interpretation of laboratory data collected to support UZ-UCSF protocols. This was a community based, cr …

Non-Network

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A5265

Completed Study

A Phase III, Open-Label, Randomized, Assessment-Blinded Clinical Trial to Compare the Safety and Efficacy of Topical Gentian Violet to that of Nystatin Oral Suspension for the Treatment of OC in HIV-1 Infected Participants in Non-US Settings Sponsors: …

ACTG

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A5273

Completed Study

Mulitcenter Study of Options for SEcond-Line Effective Combination Therapy (SELECT) Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) Protocol Summary: A5273 is a phase III, dual-arm, open-label, randomized, non-inferiority stu …

ACTG

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A5274

Completed Study

Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) Protocol Summary: A5274 is a randomized, open-label, phase IV strategy trial, where parti …

ACTG

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A5278

Completed Study

Pharmacology Substudies of A5263 and A5264 Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) The National Cancer Institute (NCI) National Institute on Dental Craniofacial Research (NIDCR) Protocol Summary: A5278 is designed to …

ACTG

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A5282

Completed Study

A Randomized, Phase II Trial to Compare an HPV Test-and-Treat Strategy to a Cytology-based Strategy for Prevention of CIN 2+ in HIV-infected Women Sponsor: US National institute of Allergy and Infectious Diseases (NIAID) Protocol Summary: A5282 is a ra …

ACTG

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P1060

Completed Study

Phase II, Parallel, Randomized, Clinical Trials Comparing The Responses To Initiation of NNRTI-based Versus PI-Based Antiretroviral Therapy in HIV-Infected Infants Who Have And Have Not Previously Received Single Dose Nevirapine For Prevention of Mothe …

IMPAACT

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P1070

Completed Study

Dose-Finding and Pharmacogenetic Study of Efavirenz in HIV-Infected and HIV/TB Co-Infected Infants and Children ≥ 3 Months to < 36 Months of Age Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) The Eunice Kennedy Shriver Na …

IMPAACT

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P1072

Completed Study

Safety and Immunogenicity of a Live, Attenuated, Rotavirus Vaccine (ROTATEQTM) In HIV-Infected and Uninfected Children Born To HIV-Infected Mothers Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) The Eunice Kennedy Shriver Na …

IMPAACT

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P1073

Completed Study

Study of Immune Reconstitution Inflammatory Syndrome (IRIS) for International Sites Initiating Highly Active Antiretroviral Therapy (HAART) in Infants and Children < 72 months of Age Sponsors: US National Institute of Allergy and Infectious Diseases …

IMPAACT

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1077BF – PROMISE

Completed Study

Promoting Maternal and Infant Survival Everywhere (PROMISE) Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Protocol Summary: 1077BF …

IMPAACT

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P1084s

Completed Study

Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMSE Protocol Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) The Eunice Kennedy …

IMPAACT

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P1104s

Completed Study

Longitudinal Developmental and Neuropsychological Assessments of HIV infected Participants of P1060 and HIV Uninfected Sponsors: US National Institute of Allergy and Infectious Diseases (NIAD) The Eunice Kennedy Shriver National Institute of Child Heal …

IMPAACT

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MTN 003D

Completed Study

An Exploratory Study of Potential Sources of Efficacy Dilution in the VOICE Trial Sponsors: Division of AIDS, US National Institute of Allergy and Infectious Diseases (NIAID) US National Institutes of Health (NIH) Protocol Summary: MTN 003D is a qualit …

MTN

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MTN 020 (ASPIRE)

Completed Study

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women (ASPIRE) Sponsors: Division of AIDS, US National Institute …

MTN

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A5185s

Completed Study

A Substudy of A5175: Effect of Initial Antiretroviral Treatment on Genital Compartment Virus in Individuals from Diverse Areas of the World Sponsor: US National Institute of Allergy and Infectious Diseases (NIAID) Protocol Summary: A5185s was a substud …

ACTG

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Non-Pneumatic Anti-Shock Garment (NASG), A First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage: A Cluster Randomized Trial

Completed Study

Sponsors: US National Institutes of Child Health and Human Development The Bill & Melinda Gates Foundation Protocol Summary: This study was a cluster randomized controlled trial to examine the effects of NASG application as a first-aid device at sa …

Non-Network

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HPTN 052

Completed Study

A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples Sponsors: Division of AIDS, US National Institute of Al …

HPTN

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MTN 003B

Completed Study

Bone Mineral Density Substudy to MTN 003 (VOICE) Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) US National Institutes of Health (NIH) Protocol Summary: MTN 003B is a substudy of MTN 003 (VOICE), whi …

MTN

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