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Dual therapy with lopinavir/ritonavir plus lamivudine could be an effective alternative for antiretroviral-therapy-naive adults with HIV-1 infection in resource-limited settings: planned 144 week, a randomized, open-label and non-inferiority study from China

Dual therapy with lopinavir/ritonavir plus lamivudine could be an effective alternative for antiretroviral-therapy-naive adults with HIV-1 infection in resource-limited settings

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024611
Enrollment
Unknown
Registered
2019-07-18
Start date
2015-03-01
Completion date
Unknown
Last updated
2019-07-22

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

Conditions

AIDS

Interventions

DT group:Dual-therapy of lopinavir/ritonavir (LPV/r) plus 3TC (DT group)
TT group:triple-therapy regimen containing tenofovir (TDF), 3TC plus efavirenz (EFV)

Sponsors

Guangzhou Eighth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. HIV-1 infected ART-native patients; 2. at least 18 years old; 3. plasma HIV-1 RNA level of more than 1000 copies/ml and CD4+ cell count over 200 cells/mm3.

Exclusion criteria

Exclusion criteria: 1. Patients who were pregnant or breastfeeding; 2. co-infected with HBV or HCV; 3. had chronic liver disease, or had active AIDS-associated opportunistic diseases within 30 days after screening; 4. had poor adherence.

Design outcomes

Primary

MeasureTime frame
Proportion of participants with plasma HIV-1 RNA less than 50 copies/ml at week 144;

Secondary

MeasureTime frame
proportion of patients with plasma HIV-1 RNA concentration less than 400 copies/ml at week 144, change in CD4+ cell count, ratio of CD4+ and CD8+ , safety, tolerability, resistance analysis in patients with virological failure, and changes of chronic immune activation indicators;

Countries

China

Contacts

Public ContactWeiping Cai

Guangzhou Eighth People's Hospital

gz8hcwp@126.com+86 13808815909

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026