Nielsen 2007 TZA.
Methods | Trial design: randomized double‐blind placebo‐controlled cross‐over trial. Participants: HIV‐positive individuals with or without Wuchereria bancrofti co‐infection. Length of follow‐up: all subjects were followed‐up at 1, 12, 13, and 24 weeks after the 1st round of treatment. The data presented in the published manuscript considered the 12‐week visit as the initial visit and the 24‐week visit as the final visit. Individuals treated at the initial visit with diethylcarbamazine (DEC) were then considered as the 'placebo' arm and those who were not treated until the 12‐week visit were the 'treatment' arm. For the purposes of this analysis, we considered only individuals with confirmed HIV‐1 infection who were also filariasis‐infected at the baseline visit. We considered individuals treated with DEC at the initial visit to be in the 'treatment' arm and those who did not receive treatment to be in the 'placebo' arm. We reported outcomes as indicated for the 12‐week visit. As all participants were treated with DEC by the 12 week visit, we did not include data from the 24‐week follow‐up period. Monitoring and diagnostics: diagnosis of infection with lymphatic filariasis (LF) infection with W. bancrofti was performed using immunochromatographic tests (ICT) followed by ELISA testing for circulating filarial antigens (CFA) in serum samples. Participants were also screened for malaria and intestinal helminth eggs. |
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Participants | Number of participants: the trial authors screened 858 adults and 34 HIV‐1 infected individuals were enrolled and randomized in the trial, of which 27 were followed‐up. Eighteen were co‐infected with W. bancrofti, and 16 were not co‐infected. In the co‐infected group, 10 participants were randomized to early treatment and 8 participants were randomized to delayed treatment. Twelve of these participants were followed‐up, 6 in each treatment group. The HIV RNA from one of the participants in the delayed treatment arm could not be amplified. Inclusion criteria: HIV‐positive individuals without clinical manifestations of HIV, with and without LF infection. Exclusion criteria: none specified. |
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Interventions | Intervention: DEC (6 mg/kg) at randomization. Control: equivalent placebo and treatment after a delay of 3 months. |
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Outcomes | Outcomes included in this review: plasma HIV‐1 RNA levels, CD4+ cell count, CD4 percent, serum concentrations of ferritin, adverse events. Other trial outcomes: CD4/CD8 ratio between individuals randomized to early versus delayed treatment (3 months later) (Nielsen 2007 TZA). Baseline and change in serum retinol, β‐carotene, α‐tocopherol, and the acute phase reactant a‐1 antichymotrypsin after 3 months (Nielsen 2009). |
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Notes | Location: Northeastern Tanzania Participant helminth status: ascertained Participation ART status: the trial authors did not specify if any participants were receiving ART treatment at the start or during the trial. Author contact: we requested additional CD4 and HIV‐1 RNA data from the trial authors, who provided the data. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Individuals were randomised (1:1). "The identical DEC and placebo tablets were packed in containers with different color codes (“red” or “blue”). Individuals were randomised (1:1) to receive treatment in the order of “red” followed by “blue” or “blue” followed by “red” by using a list of random numbers.The selected study participants were listed and numbered from 1 to 34, and the first 17 numbers (between 1 and 34) encountered in the table (when starting on a randomly chosen figure) were assigned to receive treatment in the order red–blue, and the remaining 17 received treatment in the order blue–red." |
Allocation concealment (selection bias) | Unclear risk | This was not specified. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "All study personnel and participants were blinded to treatment assignment throughout the study." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It is unclear whether or not the assessor was blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | There is a risk of attrition as there was < 80% follow‐up. However, this reflects 7 participants who were lost to follow‐up and therefore excluded from the analyses. The excluded participants did not significantly differ at baseline from the included participants. |