Trial reportAIDS research and human retroviruses2009
Early versus delayed fixed dose combination abacavir/lamivudine/zidovudine in patients with HIV and tuberculosis in Tanzania.
Trial report in AIDS research and human retroviruses, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00851630 (A Pilot Study Of Open-Label Fixed Dose Combination Zidovudine/Lamivudine/Abacavir In HIV-Infected Persons With Tuberculosis In Moshi, Tanzania; Tuberculosis And HIV Immune Reconstitution Syndrome Trial), which is not on this map. Cited by 17 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Pilot Study Of Open-Label Fixed Dose Combination Zidovudine/Lamivudine/Abacavir In HIV-Infected Persons With Tuberculosis In Moshi, Tanzania; Tuberculosis And HIV Immune Reconstitution Syndrome Trial (THIRST)
Who cites it
17 citing papers in PubMed, 4 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- What is the optimum time to start antiretroviral therapy in people with HIV and tuberculosis coinfection? A systematic review and meta-analysis.Journal of the International AIDS Society · 2021Pooled it
- Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Guideline
- Pooled it
- Co-formulated abacavir-lamivudine-zidovudine for initial treatment of HIV infection and AIDS.The Cochrane database of systematic reviews · 2013Pooled it
- Predictors and outcomes of Mycobacterium tuberculosis bacteremia among patients with HIV and tuberculosis co-infection enrolled in the ACTG A5221 STRIDE study.BMC infectious diseases · 2015Trial
- Integration of antiretroviral therapy with tuberculosis treatment.The New England journal of medicine · 2011Trial
- Association of CD4 T cell count and optimal timing of antiretroviral therapy initiation with immune reconstitution inflammatory syndrome and all-cause mortality for HIV-infected adults with newly diagnosed pulmonary tuberculosis: a systematic review and meta-analysis.International journal of clinical and experimental pathology · 2021Review
- Tuberculosis IRIS: Pathogenesis, Presentation, and Management across the Spectrum of Disease.Life (Basel, Switzerland) · 2020Review
- Effects of time of initiation of antiretroviral therapy in the treatment of patients with HIV/TB co-infection: A systemic review and meta-analysis.Annals of medicine and surgery (2012) · 2020Review
- Combination antiretroviral therapy accelerates immune recovery in patients with HIV-related lymphoma treated with EPOCH: a comparison within one prospective trial AMC034.Leukemia & lymphoma · 2018Article
- Paradoxical Reactions and the Immune Reconstitution Inflammatory Syndrome.Microbiology spectrum · 2017Review
- Review
- Bacteremic disseminated tuberculosis in sub-saharan Africa: a prospective cohort study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2012Article
- Diagnosis & treatment of tuberculosis in HIV co-infected patients.The Indian journal of medical research · 2011Review
- Review
- Pathogenesis and prevention of immune reconstitution disease during antiretroviral therapy.Expert review of anti-infective therapy · 2011Review
- Optimum time to start antiretroviral therapy during HIV-associated opportunistic infections.Current opinion in infectious diseases · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 3 countries.
Funding
Abstract
Fixed dose combination abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) among HIV-1 and tuberculosis (TB)-coinfected patients was evaluated and outcomes between early vs. delayed initiation were compared. In a randomized, pilot study conducted in the Kilimanjaro Region of Tanzania, HIV-infected inpatients with smear-positive TB and total lymphocyte count <1200/mm(3) were randomized to initiate ABC/3TC/ZDV either 2 (early) or 8 (delayed) weeks after commencing antituberculosis therapy and were followed for 104 weeks. Of 94 patients screened, 70 enrolled (41% female, median CD4 count 103 cells/mm(3)), and 33 in each group completed 104 weeks. Two deaths and 12 serious adverse events (SAEs) were observed in the early arm vs. one death, one clinical failure, and seven SAEs in the delayed arm (p = 0.6012 for time to first grade 3/4 event, SAE, or death). CD4 cell increases were +331 and +328 cells/mm(3), respectively. TB-immune reconstitution inflammatory syndromes (TB-IRIS) were not observed in any subject. Using intent-to-treat (ITT), missing = failure analyses, 74% (26/35) vs. 89% (31/35) randomized to early vs. delayed therapy had HIV RNA levels <400 copies/ml at 104 weeks (p = 0.2182) and 66% (23/35) vs. 74% (26/35), respectively, had HIV RNA levels <50 copies/ml (p = 0.6026). In an analysis in which switches from ABC/3TC/ZDV = failure, those receiving early therapy were less likely to be suppressed to <400 copies/ml [60% (21/35) vs. 86% (30/35), p = 0.030]. TB-IRIS was not observed among the 70 coinfected subjects beginning antiretroviral treatment. ABC/3TC/ZDV was well tolerated and resulted in steady immunologic improvement. Rates of virologic suppression were similar between early and delayed treatment strategies with triple nucleoside regimens when substitutions were allowed.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.