The implementation and appraisal of a novel confirmatory HIV-1 testing algorithm in the Microbicides Development...

Area of Science:

• Virology
• Immunology
• Clinical Trials

Background:

• A large Phase III microbicide trial enrolled 9385 women between 2005 and 2009.
• 537 women (6%) had positive rapid human immunodeficiency virus (HIV) tests post-enrollment.
• Trial registration: ISRCTN 64716212.

Purpose of the Study:

• To apply and evaluate a novel HIV confirmatory testing algorithm.
• To determine the primary efficacy endpoint in a large Phase III microbicide trial.
• To assess the algorithm's performance in confirming HIV infection.

Main Methods:

• Utilized archived serum and Buffy Coat samples for confirmatory testing.
• Employed a combination of assays: HIV-specific antibody detection (EIA, Western Blot), PCR for nucleic acids, and p24 antigen EIA.
• The overall sample set completion rate was over 95%.

Main Results:

• The algorithm confirmed the primary endpoint in 419 (78%) of the 537 rapid test-positive samples.
• 63 cases (12%) were confirmed HIV-positive at screening/enrollment, and 55 (10%) were confirmed HIV-negative.
• Endpoint confirmation occurred at the same visit in 90% of cases and the preceding visit in 10%.

Conclusions:

• The novel HIV testing algorithm effectively determined the primary efficacy endpoint in the microbicide trial.
• The algorithm demonstrated high performance, confirming HIV status accurately and efficiently.
• The approach is recommended for determining HIV as an endpoint in clinical trials.