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HIV Treatment and CVD Events

NCT01054638 · Status: COMPLETED · Type: OBSERVATIONAL

Last updated 2011-07-27

No results posted yet for this study

Summary

Cardiovascular disease (CVD) has been associated with HIV infection. However, it is uncertain whether increased CVD rates are associated with HIV-related factors (e.g., HIV-infection or highly active antiretroviral therapy (HAART) may worsen dyslipidemia) or reflect differences in the prevalence of underlying risk factors for CVD. Furthermore, the association between initiation and duration of HAART exposure and CVD risk, including which specific drugs within the HAART classes may contribute to the increased risk, is unknown. The primary objectives of the study are therefore:

1\. To estimate the absolute and relative incidence rate (IR) of CVD claims-based diagnoses among a cohort of adult patients from a large managed care population with a claims diagnosis of HIV, AIDS, or AIDS-related complex (ARC) during periods of exposure to:

* Any HAART compared to no HAART exposure
* HAART class \[i.e., NRTIs, NNRTIs, PIs, and Other (i.e., fusion inhibitors)\] compared to no HAART class exposure
* Specific NRTI medications compared to no specific NRTI exposure

Conditions

Interventions

DRUG

HAART Treatment

Using pharmacy records, identify all patients with HAART dispensing during baseline \& follow-up periods. For combination medications, classify person-time according to individual therapeutic components. HAART exposure classification by 1)any HAART exposure, 2)by HAART class, and 3)by specific nucleoside reverse transcriptase inhibitor exposure. Specific evaluation of fosamprenavir and amprenavir. Subdivide person-time according to recent, past \& non-use of HAART. Person-time for each patient partitioned into exposure windows of Recent use(From start of dispensing to end of days supplied plus 6 months), Past use(From end of current use to end of follow-up or new HAART dispensing following recent use), \& Non-use(Time prior to first dispensing or all time for those who did not receive a dispensing). Determine cumulative duration of exposure based on days supplied per dispensing per patient over the baseline \& follow-up periods: Non-use, Less than 1 yr, 1-2 yrs, More than 2yrs.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-12-31
Completion
2010-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01054638 on ClinicalTrials.gov