This trial is active, not recruiting.

Condition hiv-associated lipodystrophy syndrome
Treatment nucleoside analogue sparing haart regimen
Phase phase 4
Sponsor Danish HIV Research Group
Collaborator Rigshospitalet, Denmark
Start date June 2003
End date November 2007
Trial size 100 participants
Trial identifier NCT00135460, 2612-2198


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

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.
Principal investigator Niels Obel, M.D., DMSc
Trial information was received from ClinicalTrials.gov and was last updated in March 2006.
Information provided to ClinicalTrials.gov by Danish HIV Research Group.