Baseline Clinical and Demographics Characteristics of A Cohort of HIV-Infected Children Failing 1^st Line ART in Durban, South Africa Stratified by Initial Treatment Regimen and Presence of Resistance Testing.

<p>Baseline Clinical and Demographics Characteristics of A Cohort of HIV-Infected Children Failing 1^st Line ART in Durban, South Africa Stratified by Initial Treatment Regimen and Presence of Resistance Testing.</p

Univariate Analysis: Predictors of Six Month Viral Suppression After Change to Second-Line ART in a Cohort of HIV-Infected Children Failing 1^st Line ART in Durban, South Africa.

<p>Univariate Analysis: Predictors of Six Month Viral Suppression After Change to Second-Line ART in a Cohort of HIV-Infected Children Failing 1^st Line ART in Durban, South Africa.</p

Multivariate Analysis: Predictors of Six Month Viral Suppression After Change to Second-Line ART in a Cohort of HIV-Infected Children Failing 1^st line ART in Durban, South Africa.

<p>Multivariate Analysis: Predictors of Six Month Viral Suppression After Change to Second-Line ART in a Cohort of HIV-Infected Children Failing 1^st line ART in Durban, South Africa.</p

Kaplan-Meier survival curve for the impact of lopinavir/ritonavir dosing strategy among patients with HIV/TB coinfection on time until treatment discontinuation.

<p>Kaplan-Meier survival curve for the impact of lopinavir/ritonavir dosing strategy among patients with HIV/TB coinfection on time until treatment discontinuation.</p

Baseline characteristics of patients at initiation of lopinavir/ritonavir-based second line ART, according to treatment group.

<p>Baseline characteristics of patients at initiation of lopinavir/ritonavir-based second line ART, according to treatment group.</p

Clinical outcomes associated with coadministration of lopinavir/ritonavir-based ART and rifampicin-containing TB treatment.

<p>T-test, Chi-square, and Fisher’s tests used for comparisons, * p<0.05.</p

CD4 count outcomes at 12 and 30 months based on patient demographic and pre-HAART characteristics.

<p>CD4 count outcomes at 12 and 30 months based on patient demographic and pre-HAART characteristics.</p

CD4+ T-cell count trajectories and baseline characteristics predicting failure of CD4 cell count recovery.

<p><b>A</b>. CD4+ T-cell count trajectories for all 442 subjects over the course of 30 months. The red line reflects the median±SEM. <b>B</b>. OR and 95% confidence intervals (CI) for not achieving CD4 counts above 200 cells/mm³ at 12 months (grey) and 500 cells/mm³ at 30 months (black) depending on baseline characteristics. Shown are only factors with significant or close to significant effect in the multivariate model.</p

The REVAMP trial to evaluate HIV resistance testing in sub-Saharan Africa: a case study in clinical trial design in resource limited settings to optimize effectiveness and cost effectiveness estimates

<p><b>Background:</b> In sub-Saharan Africa, rates of sustained HIV virologic suppression remain below international goals. HIV resistance testing, while common in resource-rich settings, has not gained traction due to concerns about cost and sustainability.</p> <p><b>Objective:</b> We designed a randomized clinical trial to determine the feasibility, effectiveness, and cost-effectiveness of routine HIV resistance testing in sub-Saharan Africa.</p> <p><b>Approach:</b> We describe challenges common to intervention studies in resource-limited settings, and strategies used to address them, including: (1) optimizing generalizability and cost-effectiveness estimates to promote transition from study results to policy; (2) minimizing bias due to patient attrition; and (3) addressing ethical issues related to enrollment of pregnant women.</p> <p><b>Methods:</b> The study randomizes people in Uganda and South Africa with virologic failure on first-line therapy to standard of care virologic monitoring or immediate resistance testing. To strengthen external validity, study procedures are conducted within publicly supported laboratory and clinical facilities using local staff. To optimize cost estimates, we collect primary data on quality of life and medical resource utilization. To minimize losses from observation, we collect locally relevant contact information, including Whatsapp account details, for field-based tracking of missing participants. Finally, pregnant women are followed with an adapted protocol which includes an increased visit frequency to minimize risk to them and their fetuses.</p> <p><b>Conclusions:</b> REVAMP is a pragammatic randomized clinical trial designed to test the effectiveness and cost-effectiveness of HIV resistance testing versus standard of care in sub-Saharan Africa. We anticipate the results will directly inform HIV policy in sub-Saharan Africa to optimize care for HIV-infected patients.</p