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

Danish HIV Research Group

Status and phase

Unknown

Phase 4

Conditions

HIV-Associated Lipodystrophy Syndrome

Treatments

Drug: nucleoside analogue sparing HAART regimen

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00135460

2612-2198

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).