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Report for Clinical Trial NCT00557245

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples

Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples.

NCT00557245 HIV-1 Infections HIV Infections
MeSH:Infection Communicable Diseases HIV Infections

3 Interventions

Name: Tenofovir Disoproxil Fumarate (TDF)

Description: TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
Type: Drug
Group Labels: 1

Tenofovir Disoproxil Fumarate (TDF)

Name: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)

Description: FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Type: Drug
Group Labels: 1

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)

Name: Placebo

Description: Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
Type: Drug
Group Labels: 1

Placebo


Primary Outcomes

Description: The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms.

Measure: Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants

Time: Up to 36 months

Description: Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF compared to those randomized to placebo measured as the number of participants with Serious Adverse Events (SAEs) during follow-up.

Measure: Number of Participants With Serious Adverse Events (SAEs)

Time: Up to 36 months

Secondary Outcomes

Description: Adherence to study medication as assessed by pill count at follow-up visits. We assessed the total number of doses taken of the total dispensed doses.

Measure: Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.

Time: Up to 36 months

Description: Adherence to study drug measured as the percentage of visits when participants reported missing 1) any dose of study drug in the prior month and 2) 2 or more consecutive doses of study drug.

Measure: Study Drug Adherence: Self-reported Missed Doses of Study Drug

Time: Up to 36 months

Description: HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. These mutation types were pre-defined. Plasma samples for resistance testing were collected at the visit seroconversion was first detected and again at a visit within 1 month of seroconversion. Mutations detected at either of those visits are reported. Both seroconverters found to have a resistance mutation had been HIV infected at enrollment (TDF arm: n=1; FTC-TDF arm: n=1).

Measure: Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC

Time: Up to 36 months

Description: Prevalence of STIs measured as the number of participants with a positive test result for N. gonorrhoeae, C. trachomatis, or T. vaginalis during follow-up. Participants were tested for STIs at annual follow-up visits and at intervening visits at which the participant presented with symptoms of an STI. Assessment for symptomatic sexually transmitted infections was conducted quarterly. N. gonorrhoeae and C. trachomatis testing were by APTIMA Combo 2 (Gen-Probe) or COBAS Amplicor (Roche Diagnostics). T. vaginalis testing was by APTIMA TV TMA (Gen-Probe) or In Pouch TV (Biomed Diagnostics).

Measure: Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up

Time: Up to 36 months

Description: Sexual risk behavior of participants, measured as the percentage of visits when participants reported having unprotected sex during follow-up.

Measure: Prevalence of Unprotected Sex During Follow-up

Time: Up to 36 months

Description: Infant outcomes measured as the number of live-born infants born to female participants taking study drug that had any congenital anomalies.

Measure: Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.

Time: Up to 36 months

Description: The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.

Measure: Length Among Infants Born to Female Participants Taking Study Drug

Time: up to 12 months

Description: The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.

Measure: Weight Among Infants Born to Female Participants Taking Study Drug

Time: up to 12 months

Description: The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.

Measure: Head Circumference Among Infants Born to Female Participants Taking Study Drug

Time: up to 12 months

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There are 4 SNPs

SNPs


1 K65R

HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. --- K65R ---


2 K70E

HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. --- K65R --- --- K70E ---


3 M184I

HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. --- K65R --- --- K70E --- --- M184I ---


4 M184V

HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. --- K65R --- --- K70E --- --- M184I --- --- M184V ---



HPO Nodes