Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients

• ClinicalTrials.gov Identifier: NCT00135460
• Recruitment Status: Unknown
• First Posted: August 26, 2005
• Last Update Posted: March 14, 2006
• Sponsor: Danish HIV Research Group
• Collaborators: Rigshospitalet, Denmark; Hvidovre University Hospital; Odense University Hospital; Aarhus University Hospital; Aalborg University Hospital; Abbott
• Information provided by: Danish HIV Research Group

Tracking Information

• First Submitted Date: August 25, 2005
• First Posted Date: August 26, 2005
• Last Update Posted Date: March 14, 2006
• Study Start Date: June 2003
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: November 7, 2005)

• Changes in peripheral fat mass, determined by DEXA-changes
• Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination
• Change from baseline in fasting lipids and subsets hereof
• Development of impaired glucose tolerance and insulin resistance

Original Primary Outcome Measures (submitted: August 25, 2005)

• Changes in peripheral fat mass, determined by DEXA-Changes Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination.
• Change from baseline in fasting lipids and subsets hereof
• Development of impaired glucose tolerance and insulin resistance

Current Secondary Outcome Measures (submitted: November 7, 2005)

• Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks
• Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks
• Incidence of adverse events
• Incidence of clinical disease progression
• Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24, 48 and 96
• Change in plasma lactate from baseline
• Time to discontinuation of the randomized therapy and reasons for this
• Incidence of genotypical and virological resistance
• Development of osteopenia, judged by DEXA-scan
• Compliance - proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96

Original Secondary Outcome Measures (submitted: August 25, 2005)

• Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks.
• Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks.
• Incidence of adverse events.
• Incidence of clinical disease progression.
• Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24, 48 and 96
• Change in plasma lactate from baseline.
• Time to discontinuation of the randomized therapy and reasons for this.
• Incidence of genotypical and virological resistance.
• Development of osteopenia, judged by DEXA-scan.
• Compliance - proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients
• Official Title: Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV. Influence on Morphological and Metabolic Disorders. A Randomized, Open-Label Multicenter Trial.

Brief Summary

Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy.

There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy.

The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen.

The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry (DEXA)-scanning.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: HIV-Associated Lipodystrophy Syndrome
• Intervention: Drug: nucleoside analogue sparing HAART regimen
• Study Arms: Not Provided
• Publications *: Mathiesen IH, Salem M, Gerstoft J, Gaardbo JC, Obel N, Pedersen C, Ullum H, Nielsen SD, Hansen AE. Complete manuscript Title: Changes in RANKL during the first two years after cART initiation in HIV-infected cART naïve adults. BMC Infect Dis. 2017 Apr 11;17(1):262. doi: 10.1186/s12879-017-2368-y.

Recruitment Information

• Recruitment Status: Unknown status
• Enrollment (submitted: August 25, 2005): 100
• Original Enrollment: Same as current
• Study Completion Date: November 2007
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Antiretroviral naïve patients
• HIV-1 infection as documented by a licensed HIV-1 antibody ELISA.
• Fulfilling the criteria for starting antiretroviral therapy.
• Ability to understand and provide written informed consent.

Exclusion Criteria:

• Women being pregnant or breast-feeding.
• Fertile women using no safe contraception.
• Patients with active intravenous drug use.
• Abuse of alcohol, which in the opinion of the treating physician will reduce the patient´s ability to follow a therapeutic regimen and evaluations of the protocol.
• Ongoing medical treatment, which has a clinically significant interaction with lopinavir, ritonavir or efavirenz.
• Creatinine > 200 mmol/l.
• ALT or AST > 5 times upper normal value (200U/l).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT00135460
• Other Study ID Numbers: 2612-2198
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Danish HIV Research Group

Collaborators

• Rigshospitalet, Denmark
• Hvidovre University Hospital
• Odense University Hospital
• Aarhus University Hospital
• Aalborg University Hospital
• Abbott

Investigators

• Study Chair: Jan Gerstoft, M.D., DMSc; Rigshospitalet, Denmark
• Principal Investigator: Niels Obel, M.D., DMSc; Odense University Hospital
• Principal Investigator: Court Pedersen, Professor; Odense University Hospital
• Principal Investigator: Lars Mathiesen, M.D.,DMSc; Hvidovre University Hospital
• Principal Investigator: Henrik Nielsen, M.D.,DMSc; Aalborg University Hospital
• Principal Investigator: Alex Laursen, M.D., DMSc; Aarhus University City
• Principal Investigator: Ann-Brit E Hansen, M.D.; Copenhagen University Hospital Rigshospitalet and Odense University Hospital

• PRS Account: Danish HIV Research Group
• Verification Date: September 2005