A randomised control trial of structured interrupted generic antiretroviral therapy versus continuous therapy in HIV-infected individuals in Southern India.
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| Title: | A randomised control trial of structured interrupted generic antiretroviral therapy versus continuous therapy in HIV-infected individuals in Southern India. |
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| Authors: | Kumarasamy, N. (AUTHOR), Flanigan, T. P. (AUTHOR), Vallabhaneni, S. (AUTHOR), Cecelia, A. J. (AUTHOR), Christybai, P. (AUTHOR), Balakrishnan, P. (AUTHOR), Yepthom, T. (AUTHOR), Solomon, S. (AUTHOR), Carpenter, C. C. J. (AUTHOR), Mayer, K. H. (AUTHOR) |
| Source: | AIDS Care. Apr2007, Vol. 19 Issue 4, p507-513. 7p. |
| Subjects: | Antiretroviral agents, Therapeutics, HIV-positive persons, Immunologic diseases |
| Geographic Terms: | Chennai (India), India |
| Abstract: | This randomised control trial, conducted in Chennai, India, compared structured interrupted therapy (SIT) and continuous therapy (CT) in relation to immunologic and virologic outcomes, adverse events (AEs) and cost of therapy. ART-naïve adult HIV1-infected participants with CD4 counts 50-350cells/mm3, and plasma viral load (PVL)>5000copies/mL were enrolled and placed on Indian-manufactured generic ART: zidovudine(AZT)/stavudine(d4T)+lamivudine(3TC)+efavirenz(EFV). After at least six months of continuous therapy, subjects were randomised to SIT (one-week-on/one-week-off cycles) or CT. The primary end-point was the proportion of subjects maintaining CD4>200cells/mm3 at six and 12 months after randomisation. Secondary end-points were effective viral suppression (PVL<400copies/mL), AEs and cost. All analyses used intention-to-treat methodology. Of 40 participants (69% male; mean age 36±7; median baseline CD4 and PVL: 162cell/mm3and 259,000copies/mL), 17 were randomised to SIT and 18 to CT. At randomisation, median CD4s for SIT and CT were 378cells/mm3 and 357cells/mm3, respectively. All participants had PVL<400 copies/mL at time of randomisation. Median CD4 six months after randomisation was 498cells/mm3 and 417cells/mm3 for SIT and CT respectively. All participants had CD4>200cells/mm3. One participant on CT and two on SIT had sustained PVL>400copies/mL. There were no serious AEs or deaths. Structured interrupted therapy cost was half of CT. Structured interrupted therapy was effective at maintaining CD4 above 200cells/mm3. Adverse events were comparable in both groups, with 50% reduction in cost for SIT. Further research on such strategies may benefit resource-constrained settings. [ABSTRACT FROM AUTHOR] |
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| Database: | Psychology and Behavioral Sciences Collection |
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| Abstract: | This randomised control trial, conducted in Chennai, India, compared structured interrupted therapy (SIT) and continuous therapy (CT) in relation to immunologic and virologic outcomes, adverse events (AEs) and cost of therapy. ART-naïve adult HIV1-infected participants with CD4 counts 50-350cells/mm3, and plasma viral load (PVL)>5000copies/mL were enrolled and placed on Indian-manufactured generic ART: zidovudine(AZT)/stavudine(d4T)+lamivudine(3TC)+efavirenz(EFV). After at least six months of continuous therapy, subjects were randomised to SIT (one-week-on/one-week-off cycles) or CT. The primary end-point was the proportion of subjects maintaining CD4>200cells/mm3 at six and 12 months after randomisation. Secondary end-points were effective viral suppression (PVL<400copies/mL), AEs and cost. All analyses used intention-to-treat methodology. Of 40 participants (69% male; mean age 36±7; median baseline CD4 and PVL: 162cell/mm3and 259,000copies/mL), 17 were randomised to SIT and 18 to CT. At randomisation, median CD4s for SIT and CT were 378cells/mm3 and 357cells/mm3, respectively. All participants had PVL<400 copies/mL at time of randomisation. Median CD4 six months after randomisation was 498cells/mm3 and 417cells/mm3 for SIT and CT respectively. All participants had CD4>200cells/mm3. One participant on CT and two on SIT had sustained PVL>400copies/mL. There were no serious AEs or deaths. Structured interrupted therapy cost was half of CT. Structured interrupted therapy was effective at maintaining CD4 above 200cells/mm3. Adverse events were comparable in both groups, with 50% reduction in cost for SIT. Further research on such strategies may benefit resource-constrained settings. [ABSTRACT FROM AUTHOR] |
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| ISSN: | 09540121 |
| DOI: | 10.1080/09540120701213849 |
