HVTN 703/HPTN 081 (AMP Study): A phase 2b study to evaluate the efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection in women in Sub- Saharan Africa.
Network Studies

Principal Investigator - Dr. Shahin Lockman MD, MPH

Study Objectives 

Primary Objectives

  • To evaluate the safety and tolerability of VRC01 mAb administered through IV infusion in sub-Saharan African women.
  • To determine if the VRC01 mAb prevents HIV-1 infection and to estimate the level of efficacy in sub-Saharan African women. 

Study Design: Multicenter, randomized, controlled, double-blind trial.

HVTN805/HPTN093: Antiretroviral analytical treatment interruption (ATI) to assess immunologic and virologic responses in participants who initiated ART in early HIV infection after having received VRC01 or placebo in HVTN 703/HPTN 081.
Network Studies

Principal Investigator - Dr. Shahin Lockman MD, MPH

Study Objectives

Primary Objectives

  • To evaluate the effect of early ART initiation, with or without having received VRC01 in the immediate pre-HIV acquisition period and/or during early infection, on the time to meeting ART re-initiation criteria in participants undergoing ATI.
  • To evaluate the safety of ATI among HVTN 805/HPTN 093 participants.

Secondary Objectives

IMPAACT 2005
Network Studies

Principal Investigator - Dr. Shahin Lockman MD, MPH

Study Title: IMPAACT 2005 - Phase I/II Open-label, Single-Arm Study to Evaluate Pharmacokinetics (PK), Safety, and Tolerability of Delamanid (DLM) in Combination with Optimized Multidrug Background Regimen (OBR) for Multidrug Resistance-Tuberculosis (MDR-TB) in HIV-infected and HIV-uninfected Children with MDR-TB

Study Objectives

Primary Objectives 

IMPAACT 2017 - Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents
Network Studies

Principal Investigator - Dr. Shahin Lockman MD, MPH

Study Objectives

Primary Objectives

Cohort 1 (continuing a background cART regimen)

IMPAACT 2019 – Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less than 12 Years of Age
Network Studies

Principal Investigator - Dr. Shahin Lockman MD, MPH

Study Objectives

Primary Objectives

Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern: CoVPN 3008
Network Studies

Principal Investigator - Dr. Joseph Moeketsi Makhema MB.ChB, FRCP

Study Objectives

Primary Objectives:

Open-Label, Single-Arm, Phase 3B Study of the Incidence of Severe COVID-19 and Adverse Events Following AZD1222 COVID-19 Vaccination in Botswana Against SARS-CoV-2
Network Studies

Principal Investigator - Dr. Joseph Moeketsi Makhema, MB.ChB, FRCP

P1093 - Phase I/II, Multi-Centre, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents
Network Studies

Principal Investigator - Dr. Shahin Lockman MD, MPH

Study Objectives

Primary Objectives

PHOENIx (A5300B): Protecting Households on Exposure to Newly Diagnosed Index Multidrug Resistant TB patients
Network Studies

Principal Investigator - Dr. Shahin Lockman MD, MPH

Study Objectives

Primary Objectives

Among HIV-infected and other child, adolescent, and adult HHCs of MDR-TB patients at high risk of developing TB:

REPRIEVE (A5332): A randomized trial to prevent vascular events (such as stroke and heart attack) in people living with HIV.
Network Studies

Principal Investigator - Dr. Shahin Lockman MD, MPH

Study Objectives

Primary Clinical Objective

  • To determine the effects of Pitavastatin as a primary prevention strategy for Major Adverse Cardiovascular Events (MACE) in HIV

Secondary Objectives