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A LOCAL STUDY OF 48 WEEKS, IN OPEN MODALITY, WITH A SINGLE TREATMENT GROUP, ABOUT THE EFFICACY, SAFETY AND TOLERABILITY OF TRIZIVIR (ABACAVIR, 300 MG / LAMIVUDINA, 150 MG / ZIDOVUDINA, 300 MG IN COMBINATION IN A THERAPY TWICE PER DAY) ADMINISTERED TO SUBJECTS PERUVIAN HISPANIC ADULTS INFECTED BY HIV-1 WITHOUT PREVIOUS ANTIRETROVIRAL TREATMENT, WITH BASAL RECOADS OF CD4 LYMPHOCYTES <400 CELLS / MM3).

A LOCAL STUDY OF 48 WEEKS, IN OPEN MODALITY, WITH A SINGLE TREATMENT GROUP, ABOUT THE EFFICACY, SAFETY AND TOLERABILITY OF TRIZIVIR (ABACAVIR, 300 MG / LAMIVUDINA, 150 MG / ZIDOVUDINA, 300 MG IN COMBINATION IN A THERAPY TWICE PER DAY) ADMINISTERED TO SUBJECTS PERUVIAN HISPANIC ADULTS INFECTED BY HIV-1 WITHOUT PREVIOUS ANTIRETROVIRAL TREATMENT, WITH BASAL RECOADS OF CD4 LYMPHOCYTES <400 CELLS / MM3).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-029-03
Enrollment
Unknown
Registered
2003-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trizivir (Abacavir 300 mg / lamivudine150 mg / Zidovudine 300 mg) Type of group
TRIZIVIR (300 mg of Abacavir / 150 mg of lamivudine / 300 mg of Zidovudine) in triple combination tablet. twice perday.

Sponsors

GLAXOSMITHKLINE PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult subjects, males or females> 18 years of age. 2. That the subject is infected by VHi-l, confirmed with at least one positive Westem Blot test for antibodies against HIV. 3. The subject requires Antinetroviral Therapy (ART), as established by the local standards of care (CD44 lymphocyte counts <400 cells / mm ^ in the selection). 4. The subject has not received antiretroviral therapy previously (that is, the subject has never received any antiretroviral therapy).

Exclusion criteria

Exclusion criteria: 1. Subject with an opportunistic infection or disease that defines AIDS according to the 1993 definition for AIDS surveillance purposes 2. That the person is pregnant or breastfeeding. 3. That, in the opinion of the researcher, it is unlikely that the subject completes the administration period for 48 weeks, as well as the evaluations and evaluations in the protocol, as well as compliance with the administration regime of the drug under study. 4. That the subject has some pre-existing mental, physical or substance abuse disorder, which, in the opinion of the researcher, could interfere with the subject´s ability to comply with the administration scheme and with the evaluations and evaluations of the protocol. 5. That the subject is afflicted by any serious medical condition, such as diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction; which, in the opinion of the researcher, could compromise the subject´s safety. 6. That the subject has a history of clinically relevant hepatitis 6 months before the selection.

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)