Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.

Danish HIV Research Group

Status and phase

Completed

Phase 4

Conditions

Lipoatrophy

Hypercholesterolemia

HIV

HIV Associated Lipodystrophy Syndrome.

Treatments

Drug: Different HAART regimens

Study type

Interventional

Funder types

Other

Identifiers

NCT00139178

26122450

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.

The main hypothesis of the study is that switching from thymidine-analogue based HAART will reverse lipoatrophy.

We plan to perform an observational study recruiting up to 100 HIV-infected patients receiving Trizivir (zidovudine/lamivudine/abacavir).

The patients will be offered an NRTI or lopinavir/ritonavir instead of zidovudine or they can choose to continue with Trizivir.

The main endpoint is changes in peripheral fat mass as determined by DEXA-scanning.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Currently treated with lamivudine, zidovudine and abacavir
Viral load < 200 copies/ml
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.
Creatinine > 200 mmol/l.
ALT or AST > 5 times upper normal value (200U/l).