Institution
AIDS Clinical Trials Group
Nonprofit•Boston, Massachusetts, United States•
About: AIDS Clinical Trials Group is a nonprofit organization based out in Boston, Massachusetts, United States. It is known for research contribution in the topics: Zidovudine & Didanosine. The organization has 90 authors who have published 66 publications receiving 4099 citations.
Topics: Zidovudine, Didanosine, Maintenance therapy, Viral load, Saquinavir
Papers published on a yearly basis
Papers
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TL;DR: In an essay, Karine Dubé and coauthors discuss the ethics of preclinical and clinical studies relevant to achieving an HIV cure.
Abstract: In an essay, Karine Dube and coauthors discuss the ethics of preclinical and clinical studies relevant to achieving an HIV cure.
20 citations
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TL;DR: A considerable amount of HIV cure-related clinical research is under way and the results from these studies, which should help shape the future of the field, will become available over the next 2–4 years.
Abstract: Objectives The community-based organisation Treatment Action Group has established an online listing of HIV cure-related trials and observational studies derived from trial registries. Our objective was to use the listing as a basis for a landscape analysis of the current status of HIV cure-related clinical research. Methods Trials and observational studies listed as of August 2018 formed the sample set. Survey questions were developed on trial development, trial design, recruitment, enrolment, study completion and dissemination plans. A survey was sent to the contact(s) for each study. Supplemental information was collected from clinicaltrials.gov. The full dataset was then analysed. Results A total of 99 interventional trials and 29 observational studies were included. Diverse interventions are under evaluation, including combinations of experimental candidates. Current studies plan to enrol over 7000 participants. Projected completion dates for ~90% of the sample fell between the fourth quarter of 2018 and the end of 2020. Potential obstacles to enrolment that were reported included concerns over invasive procedures and lack of potential benefit to participants. Data on the sex and ethnicity of enrollees were limited but sufficient to note a significant under-representation of women. Conclusions A considerable amount of HIV cure-related clinical research is under way. The results from these studies, which should help shape the future of the field, will become available over the next 2–4 years. Diversity both geographically and in terms of enrollees remains limited, particularly in terms of the participation of women, a concern that could significantly affect the generalisability of the findings.
19 citations
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Anschutz Medical Campus1, Harvard University2, University of Alabama at Birmingham3, Veterans Health Administration4, University of North Carolina at Chapel Hill5, Northwestern University6, Indiana University – Purdue University Indianapolis7, AIDS Clinical Trials Group8, National Institutes of Health9
TL;DR: Substituting DLV for 3TC when adding IDV improved virologic outcome in nucleoside-experienced patients, and might be explained, in part, by the positive effect of DLV on IDV pharmacokinetics.
Abstract: OBJECTIVE To compare the virologic activity of continued lamivudine (3TC) versus a switch to delavirdine (DLV) when initiating protease inhibitor therapy in nucleoside-experienced patients. DESIGN Randomized, open-label, multi-center study. SETTING Adult AIDS clinical trials units. PATIENTS Protease and non-nucleoside reverse transcriptase inhibitor-naive patients who had received 3TC plus zidovudine (ZDV), stavudine (d4T), or didanosine (ddl) for at least 24 weeks. INTERVENTIONS Patients with plasma HIV-1 RNA levels > 500 copies/ml who previously received d4T + 3TC or ddI + 3TC were randomized to ZDV + 3TC + indinavir (IDV) or ZDV + DLV + IDV. MAIN OUTCOME MEASURES Primary endpoints were the proportion of patients with plasma HIV-1 RNA levels < or = 200 copies/ml at 24 weeks, and occurrence of serious adverse events. The proportion of patients with plasma HIV-1 RNA levels < or = 200 copies/ml at week 48 was a secondary endpoint. RESULTS At week 24, 58% of subjects in the ZDV + 3TC + IDV arm and 73% in the ZDV + DLV + IDV arm had plasma HIV-1 RNA levels < or = 200 copies/ml (P = 0.29). At week 48, plasma HIV-1 RNA levels were < or = 200 copies/ml in 48% and 83%, respectively (P = 0.007). Rash and hyperbilirubinemia occurred more frequently in the DLV arm than in the 3TC arm. Steady-state plasma IDV levels were higher among patients in the DLV arm as compared with the 3TC arm. CONCLUSIONS Substituting DLV for 3TC when adding IDV improved virologic outcome in nucleoside-experienced patients. This result might be explained, in part, by the positive effect of DLV on IDV pharmacokinetics.
19 citations
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TL;DR: Embedding HIV prevention services in the family planning setting was feasible in this pilot because the proportion of women screened for PrEP rapidly increased, and staff knowledge and comfort discussing PrEP improved after education.
Abstract: We aimed to systematically evaluate the feasibility of integrating HIV prevention services, including pre-exposure prophylaxis (PrEP), into a family planning setting in a high-prevalence community. We used the RE-AIM Framework (Reach, Efficacy, Adoption, Implementation, Maintenance) to evaluate the integration of HIV prevention services into a family planning clinic over 6 months. Before the integration, PrEP was not offered. We implemented a staff training program on HIV PrEP. We determined the proportion of women presenting to the clinic who were screened, eligible for, and initiated PrEP through chart review. We assessed staff comfort with PrEP pre- and post-integration. We compared planned and actual implementation, interviewed staff to determine barriers and facilitators, and tracked systems adaptations. We assessed maintenance of PrEP after the study concluded. There were 640 clinical encounters for 515 patients; the rate of HIV counseling and PrEP screening was 50%. The rate was 10% in month 1 and peaked to 65% in month 3. Nearly all screened patients were eligible for PrEP (98.4%) and 15 patients (6%) initiated PrEP. Staff knowledge and comfort discussing PrEP improved after education. Facilitators included partnering with local experts, continuing education, clinical tools for providers, and patient education materials. Barriers included competing priorities during clinical encounters, limited woman-centered patient education materials, and insurance-related barriers. Embedding HIV prevention services in the family planning setting was feasible in this pilot. The proportion of women screened for PrEP rapidly increased. In this high HIV prevalence community, nearly all screened women were eligible and 6% initiated PrEP.
18 citations
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TL;DR: The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.
Abstract: International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.
18 citations
Authors
Showing all 90 results
Name | H-index | Papers | Citations |
---|---|---|---|
Michael S. Saag | 110 | 480 | 62247 |
Thomas C. Merigan | 98 | 514 | 33941 |
Martin S. Hirsch | 82 | 322 | 32239 |
Robert W. Shafer | 77 | 276 | 21133 |
Margaret A. Fischl | 72 | 258 | 27639 |
Alan Forrest | 63 | 282 | 14625 |
Gregory K. Robbins | 52 | 127 | 12285 |
Janet Andersen | 51 | 136 | 10648 |
Roland L. Bassett | 47 | 308 | 11802 |
Hulin Wu | 45 | 158 | 6353 |
Gene D. Morse | 39 | 236 | 5837 |
John S. Lambert | 38 | 195 | 4739 |
Mary Culnane | 24 | 33 | 9626 |
Qing Ma | 23 | 104 | 1757 |
Robin DiFrancesco | 20 | 57 | 1093 |